Bimbo Qsr Jobs in Usa
75 positions found
General Manager β Tamarac, FL β Up to $65K
We are currently hiring a General Manager to lead a high-volume quick-service restaurant in Tamarac, Florida. This is an opportunity to join a well-established brand known for strong community presence, authentic flavors, and fast-paced operations.
Key Responsibilities:
- Oversee all daily restaurant operations, ensuring strong service standards and consistent food quality
- Lead, develop, and motivate a team of managers and hourly employees
- Maintain full P&L responsibility including labor management, food cost, and overall financial performance
- Drive a culture focused on accountability, hospitality, and operational excellence
- Ensure compliance with all company policies, procedures, and health & safety standards
- Support local marketing initiatives and community engagement to drive sales
Requirements:
- 3+ years of General Manager or senior restaurant management experience
- Background in QSR or fast-casual, high-volume environments preferred
- Proven ability to lead and develop teams in fast-paced operations
- Strong understanding of labor management, cost control, and P&L performance
What are we looking for? The good news is that your training will teach you everything you need to know to succeed on the job. But there are a few skills you should have from the get-go: You're a fun and friendly person who values customers and takes absolute pride in everything you do. Verbal communication skills are key β you're not going to be able to text message customers back and forth. In other words, you should be comfortable talking to strangers. You've got attitude - the right kind of course - and understand the need to be on time, all the time. With loads of energy, you understand that work is easier β and more fun β with some teamwork.
Responsibilities:
-Knowledge of proper safe handling techniques for all food or chemicals used
-Anticipates kitchen member needs by constantly evaluating environment and responding to cues as necessary
-Maintain a high standard of cleanliness and orderliness in all kitchens, loading dock, dumpster and utility work areas
-Assists with receiving delivery of product on behalf of our restaurant team
-Complete daily and weekly checklists
-Maintain a proactive approach to the health, safety and security of all staff at all times
-Be vigilant for any hazards, alerting a manager as necessary
-Greet guests and provide a memorable experience
-When necessary, resolve guest issues
-Share your positive high energy and enthusiasm with focus and commitment to exceed customers expectations
-Not only will you work with our crew members, you will be part of an overall team helping to support the success of Blaze Pizza - Granville
-Bring your outgoing personality and smiles
We can't wait to see you for an interview for our full time or part time crew member position at Blaze Pizza - Granville. Apply now!
What are we looking for? The good news is that your training will teach you everything you need to know to succeed on the job. But there are a few skills you should have from the get-go: You're a fun and friendly person who values customers and takes absolute pride in everything you do. Verbal communication skills are key β you're not going to be able to text message customers back and forth. In other words, you should be comfortable talking to strangers. You've got attitude - the right kind of course - and understand the need to be on time, all the time. With loads of energy, you understand that work is easier β and more fun β with some teamwork.
Responsibilities:
-Knowledge of proper safe handling techniques for all food or chemicals used
-Anticipates kitchen member needs by constantly evaluating environment and responding to cues as necessary
-Maintain a high standard of cleanliness and orderliness in all kitchens, loading dock, dumpster and utility work areas
-Assists with receiving delivery of product on behalf of our restaurant team
-Complete daily and weekly checklists
-Maintain a proactive approach to the health, safety and security of all staff at all times
-Be vigilant for any hazards, alerting a manager as necessary
-Greet guests and provide a memorable experience
-When necessary, resolve guest issues
-Share your positive high energy and enthusiasm with focus and commitment to exceed customers expectations
-Not only will you work with our crew members, you will be part of an overall team helping to support the success of Blaze Pizza - Granville
-Bring your outgoing personality and smiles
We can't wait to see you for an interview for our full time or part time crew member position at Blaze Pizza - Granville. Apply now!
Instructional Designer (QSR / Operations Training)
Location: Remote/Hybrid in a main Steak n Shake Market
Department: Learning & Development
Reports to: VP Training
Steak n Shake is seeking an experienced Instructional Designer to create engaging, performance-driven training for our restaurant and corporate teams. This role partners closely with Operations and cross-functional teams to deliver learning that improves execution, guest experience, and retention.
This position is ideal for a learning professional who combines strong instructional design expertise with an understanding of quick-service restaurant (QSR), retail, or hospitality operations.
Responsibilities
- Design and develop eLearning, instructor-led training, and job aids for frontline and leadership roles
- Apply adult learning theory and instructional design models (ADDIE, SAM)
- Align training with operational initiatives, menu changes, and promotions
- Develop and manage content in the LMS; incorporate video and interactive learning
- Evaluate training effectiveness using feedback, LMS data, and field metrics
- Partner with Operations to pilot, refine, and roll out training programs
- Visiting restaurants to observe operations, validate effectiveness, and gather feedback
Qualifications
- Bachelorβs degree in Instructional Design, Education, or related field, Masterβs degree a plus
- 5+ years instructional design experience (QSR, retail, or hospitality preferred)
- 5+ yearsβ experience training frontline hourly teams and managers
- Proficiency (3-5 yearsβ experience) with eLearning tools (Articulate Storyline/Rise, Camtasia, Canva, Adobe, Vyond)
- Strong communication, project management, and stakeholder collaboration skills with proven ability to meet deadlines
- Data driven mindset with the ability to evaluate learning impact using Kirkpatrick type frameworks
- Knowledge of food safety standards, QSR standards, and hospitality principles
Additional Details
- You are in one of the following areas: Indianapolis, Cincinnati, Nashville, St. Louis, Atlanta, Tampa, Orlando
- Average 5% travel for field observation, analysis, and implementation evaluation
- Passion for operational excellence and learner-centered design
- Role is fast-paced, operations-driven with high visibility and impact
- Opportunity to directly influence guest experience, team performance/retention
About Steak n Shake
Steak βn Shake is a classic American brand born on Route 66 in 1934. We are the creators of the Steakburger, extraordinary homemade milkshakes, and famous beef tallow fries. We use higher quality ingredients. We care about our people by proudly being the maximum wage employer. We seek to lead in food quality and service and embrace leading technologies such as Bitcoin. We are proud to be an American company.
A leading GC operating in the QSR sector are expanding their Preconstruction team and seeking an experienced Estimator to support our pipeline of fast-paced, high-quality commercial projects.
About the Role
- You will be responsible for preparing detailed and accurate cost estimates by reviewing plans, specifications, and project scopes.
- Youβll play a key role in helping us deliver successful remodels, tenant improvements, and ground-up builds across the Western U.S.
- I am especially interested in candidates with fast-food/QSR and retail/convenience store project experience, including work with major brands such as McDonaldβs, Chick-fil-A, Chipotle, and Raising Caneβs.
To be considered for the role you must have:
- Proven experience as a Construction Estimator in commercial construction.
- Strong understanding of remodel, ground-up, and T.I. (tenant improvement) projects.
- Experience with fast-food/QSR and retail/convenience store construction is a strong plus.
- Ability to read and interpret architectural/engineering drawings with accuracy.
- Strong communication and organizational skills with the ability to manage multiple concurrent estimates.
If you thrive in a dynamic environment and enjoy the challenge of producing accurate, competitive bids, weβd love to talk to you.
Restaurant Director (QSR) - High Volume - Multi Unit
Earn $100K-$115K and Great Benefits!
We build our business through our people.
Now Hiring at
Delaware Welcome Center
520 JFK Memorial Hwy, Newark, DE 19702
Join our amazing team and come grow with us!
What We Do
At Applegreen, we Refresh Travelers on their Journeyβ¦. Applegreen USA operates over 80 travel plazas across the Northeast and Midwest that provide convenience, comfort, retail, and an extensive range of delicious food options such as Auntie Anneβs, Burger King, Chick-fil-A, Cinnabon, Dunkin Donuts, Panda Express, Panera, Popeyes, Pret, Shake Shack, Starbucks, and many more.
Our Core Values
Our Core Values are what we stand for. They guide and motivate our attitudes and behaviors to our customers, our suppliers, our business partners, and each other.
- Our customers and communities are at the heart of everything we do.
- We value and develop our people.
- We are driven by pace, passion and performance.
- We seek opportunities and embrace change.
Benefits
- Flexible Schedules
- Medical/Dental/Vision Insurance
- Paid Time Off
- 401 (k) with Company Match
- Earned Wage Access β Pay on Demand
- Education Assistance
- Employee Referral Bonus
- Meal Discount
- Pet Insurance
What youβll Do:
As the Restaurant Director (QSR) - High Volume - Multi Unit, you will be responsible for managing the overall day-to-day operations and long-term profitability of a multi-million-dollar travel plaza located along a major highway. This position is charged with sustainably achieving or exceeding targeted financial and performance metrics by successfully leading a dedicated team to ensure our customers (travelers) receive fast and friendly service.
- Lead the day-to-day activities of associates and plaza leadership to achieve or exceed targeted objectives around sales, speed of service, customer satisfaction, brand standards, and food quality & safety standards.
- Monitor and analyze progress towards targeted financial and performance objectives then implement strategic changes to sustainably maximize performance and profitability.
- Ensure that each food and beverage concept within the plaza is adhering to the required brand standards.
- Maintain an engaging work culture of continuous learning, information/skill sharing and professional development, including modeling behavior and fostering a culture of accountability.
- Consistently recruit, develop, and retain strong teams to maintain appropriate staffing levels across the plaza.
- Responsible for the hiring, coaching, training, promotion, disciplinary action, termination, or transfer of plaza leadership.
- Supervise and manage the plaza leadership team to ensure they are meeting their individual goals, their business goals, and appropriately supervising & managing their direct reports.
- Ensure compliance with company policies & procedures along with local, state, & federal laws.
- Handle customer inquiries and complaints in a professional and timely manner
- Work collaboratively with a variety of support partners such as Brand Partners, Human Resources, Loss Prevention, Finance, and Facilities & Maintenance.
- Ensure seamless, cooperative relationships with business partners, vendors, and the communities.
Essential Experience & Skills
- Utilize computerized software and systems such as Microsoft Office, payroll & time keeping software, inventory management software, and various point-of-sales systems.
- Passionate about helping people learn and grow their careers.
- Ability to operate in and navigate through ambiguity, drive clarity, and effectively manage change in a fast-paced environment.
- Demonstrate excellent communication and collaboration skills.
- Possess a proven background in maintaining strong cost control and quality standards.
- Proven ability to drive profitable growth while improving customer and associate satisfaction.
- ServSafe Certification Preferred
Requirements
- 5+ years of proven success in multi-unit or big-box leadership
- Available to work a flexible on-site schedule approximately 50 hours per week including days, nights, weekends, and holidays.
- Maintain regular and consistent attendance and punctuality, with or without reasonable accommodation.
- Able to stand and walk for an extended period of time; frequently bend, twist, lift and carry at least 20 pounds.
- Occasionally attend meetings or travel to support other locations.
This is not an exhaustive list of all functions that may be required to perform, and the employee may be required to perform additional functions. Additionally, the job responsibilities may change at any time as necessitated by business demands. Equal Opportunity Employer (EOE), Minority/Female/Disabled/Veteran (M/F/D/V), and Drug Free Workplace (DFW).
We strive to do great things for each other, our customers, our partners, our communities, and our planet. We believe a career should develop your talents, fuel your passions, and empower your professional growth. So, whatever youβre pursuing β a new challenge, a sense of belonging, or just a great place to work β Applegreen is for you!
Interested Candidates please send your resume.
Applegreen
Come grow with us!
Applegreen is an EEO Employer
Drug Free Workplace
Job Type: Full-time
Work Location: In person
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted hypothermic preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time. Paragonix also markets transplant services and organ screeningto the transplant community.
Position Overview: The Design Quality Engineer will play a crucial role in ensuring the quality and compliance of Paragonix's medical device products throughout the design and development lifecycle. The successful candidate will collaborate closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and quality assurance, to drive excellence in design control processes.
Primary responsibilities/authority will include:
- Design Control Compliance: Implement and maintain design control processes in accordance with applicable regulatory standards (e.g., ISO 13485, ISO 14971, FDA QSR, MDR) to ensure the development of safe and effective medical devices.
- Risk Management: Lead and contribute to risk management activities throughout the design process, including the identification, assessment, and mitigation of potential risks. Work closely with the R&D team to integrate risk management into the design process.
- Failure Analysis: Assist in Post-Market Surveillance (PMS) initiatives, including failure investigation, record review, and data trending.
- Quality Planning: Develop and execute quality plans for new product development projects, outlining quality objectives, deliverables, and verification/validation activities.
- Design Input and Output:
- Review and approve design inputs to ensure they are clear, complete, and aligned with user needs and regulatory requirements.
- Validate that design outputs meet the specified design input requirements.
- Change Control: Manage design changes by assessing their impact on product quality, ensuring proper documentation, and obtaining necessary approvals.
- Verification and Validation:
- Develop and execute protocols for design verification and validation strategies and acceptance criteria.
- Collaborate with testing teams to ensure thorough testing of product designs.
- Collaboration: Work closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and quality assurance, to facilitate effective communication and collaboration throughout the product development process.
- Regulatory Compliance: Stay abreast of relevant regulations and standards and ensure that product designs comply with applicable requirements. Support regulatory submissions as needed.
- Continuous Improvement: Identify opportunities for process improvements within the design control system and contribute to the development and implementation of best practices.
Required Qualifications:
- Bachelor's degree in engineering or a related field; advanced degree preferred.
- Minimum of 1-3 years of experience in a quality engineering role in the medical device industry.
- In-depth knowledge of design control processes, risk management, and quality management systems (ISO 13485, ISO 14971, FDA QSR).
- Strong technical skills related to product quality including VOE translation to Design Specs, Human Factors, CTQ Cascades, Design Characterization, Verification / Validation, Test Method Validation, Process Validation, Inspection Techniques and Statistics.
- Strong understanding of regulatory requirements for medical devices (FDA, EU MDR, etc.).
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
- DFSS or DMAIC Black Belt Certified, ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification is a plus.
Other Requirements:
- Electrical and mechanical background strongly preferred.
- Experience creating and analyzing charts in Minitab, JMP, or equivalent software a plus.
- Knowledge of Six Sigma, Lean, SPC, ASQ and/or ISO process controls a plus.
- Computer proficiency in MS office (specifically Excel).
- Effective verbal and excellent technical writing skills.
- Excels at generating and maintaining organized and accurate records.
- Excellent oral and written communication skills in English.
- Able to travel domestically and internationally as required (
Job Summary
The Manufacturing Engineer II supports the design, development, and improvement of manufacturing processes. This role is responsible for creating and maintaining key manufacturing documentation such as PFMEAs, process flow diagrams, manufacturing cell and line layouts, process routers, equipment qualifications, validation protocols, and work instructions. The engineer works cross-functionally to transfer products into production and support ongoing manufacturing operations. This role also helps implement lean manufacturing practices to improve efficiency, quality, and continuous improvement.
Duties and Responsibilities
- Design and develop manufacturing processes, select equipment, create work instructions, perform process validations (IQ/OQ/PQ), and train production staff.
- Develop, validate, and implement automated, semi-automated, and manual assembly and test equipment for disposable product manufacturing, ensuring proper documentation, calibration, and preventive maintenance.
- Participate in FMEA activities to identify and mitigate process risks.
- Collaborate with Design Engineering and Quality teams to ensure products are designed for manufacturability while meeting cost, quality, and performance requirements.
- Work with Quality and R&D to maintain compliance with internal quality systems and regulatory standards including FDA GMP, QSR, and ISO 13485.
- Support pilot production and develop lean manufacturing cells to improve throughput and product quality.
- Assist production teams by ensuring operators are trained, schedules are followed, and production documentation is accurate. Identify opportunities for process improvement.
- Continuously improve manufacturing processes related to safety, quality, lead time, productivity, and cost.
- Investigate manufacturing issues using NCMR and CAPA systems, determine root causes, and implement corrective and preventive actions.
Must Haves
- Bachelorβs degree in Mechanical Engineering, Manufacturing Engineering, Mechanical Engineering Technology, or related field required.
- 5+ years of engineering experience
- 3+ years of medical device manufacturing
- Experience with 3D CAD software (SolidWorks preferred; AutoCAD or Pro/Engineer acceptable).
- Understanding of FDA GMP, QSR, and ISO 13485 requirements.
Nice to Haves
- Six Sigma Black Belt certification is a plus.
- Lean Manufacturing certification is a plus.
- Knowledge of electromechanical component and assembly design and fabrication.
Field Director of Operations β New York CityΒ
Our agency is partnering with a global quick service brand undergoing an exciting rebrand and repositioning - moving toward a more elevated, tech-forward guest experience across its corporate locations in New York City.
Weβre looking for a Field Director of Operations to oversee 9 locations (growing to 13 by year-end). This is a highly visible, hands-on role for someone who thrives in-store, with teams, and in the day-to-day operation.
This is not a sit-back leadership role,Β youβll be on the ground, driving performance, coaching teams, and helping shape the next chapter of the brand.
What Youβll Be Doing
- Overseeing operations across corporate-owned QSR locations in NYC
- Spending significant time in-store supporting teams and driving execution
- Leading, coaching, and developing General Managers and leadership teams
- Driving consistency in service, standards, and guest experience
- Supporting the rollout of new brand standards, systems, and technology initiatives
- Managing financial performance including sales, labor, cost control, and profitability
- Identifying operational gaps and implementing practical, scalable improvements
What Weβre Looking For
- Multi-unit leadership experience in quick service or fast casual environments
- Exposure to Franchiseeβs
- Strong financial acumen with hands-on P&L ownership
- A high-energy, floor-focused leader who leads by example
- Experience working in high-volume, fast-paced operations
- Comfortable in evolving environments - especially during brand transformation or growth phases
This position is open to emerging talent ready to step into a bigger role. Due to this, salary range is $120,000 to $170,000 depending on experience!
If youβre a hands-on operator who loves being in the business, developing teams, and driving real operational change, this is a great opportunity to step into a key leadership role.
Confidential search. Only shortlisted candidates will be contacted. Applicants must have full legal authorization to work in the U.S
At a Glance
Company: Karl Storz
Location: Franklin, MA (On-site)
Job Type: Full-Time
Pay Range: $33.56 β $43.56 per hour (DOE)
Shift: Day Shift | Monday β Friday
Overtime: As Needed
Experience Level: Senior (5+ years machining/programming experience)
Industry: Medical Device Manufacturing
Apply: Directly through hireCNC
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Why This Role Exists
This role exists to support new product development, process optimization, and ongoing production needs in a high-precision medical manufacturing environment.
At Karl Storz, this position plays a critical role in creating CNC programs, processes, tooling strategies, and fabrication documentation for complex surgical components β ensuring quality, repeatability, and manufacturability at scale.
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The Work Youβll Be Doing
In this role, you will:
- Develop and optimize CNC programs using Esprit CAM
- Create machining processes, tooling packages, and setup documentation
- Support new product launches through process validation and verification
- Review drawings for manufacturability and cost reduction opportunities
- Troubleshoot machining issues and implement corrective actions
- Support MRB activities and continuous improvement initiatives
- Lead programming improvements tied to Lean manufacturing (SMED, Poka-Yoke)
- Collaborate with engineering, quality, and production teams across shifts
- Ensure compliance with ISO 13485, ISO 9001, and FDA QSR requirements
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Machines, Controls & Software
Machines: Multi-axis mills, Swiss-style lathes, mill-turn equipment
CAM Software: Esprit
CAD Software: SolidWorks
Controls: Fanuc-style environments common in Swiss and mill-turn systems
Inspection & Quality Tools: SPC methods, GD&T-driven inspection
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Materials Youβll Work With
- Stainless Steel
- Nitinol
- Nickel Alloys
- Other medical-grade metals
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What Weβre Looking ForRequired:
- 5+ years of machining or CNC programming experience
- Strong CNC machining background including setups and tooling strategy
- Proficiency with Esprit CAM or similar multi-axis programming software
- Ability to read and interpret complex blueprints and GD&T
- Experience optimizing cycles, processes, and manufacturability
- Strong troubleshooting and problem-solving skills
- Excellent communication and documentation ability
Preferred:
- Experience with Swiss-turn or mill-turn equipment
- Fixture and tooling design experience
- SPC knowledge
- SAP experience
- Medical device or regulated manufacturing experience
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Why Machinists & Programmers Like Working Here
Professionals choose Karl Storz because:
- Clean, modern, climate-controlled facility
- High-end multi-axis equipment
- Stable workload in medical manufacturing
- Competitive pay and strong benefits
- Tuition reimbursement (up to $5,250/year)
- 401(k) with 60% match on first 6%
- 3 weeks vacation + 11 paid holidays
- Up to 8 weeks fully paid parental leave
- Real impact β components used in life-saving medical devices
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Pay, Benefits & Schedule
Pay Range: $33.56 β $43.56/hr (based on experience)
Benefits Include:
- Medical, dental, vision
- 401(k) with company match
- PTO + paid holidays
- Tuition reimbursement
- Parental leave
- Life, STD/LTD insurance
- Flexible Spending Accounts
- Wellness and fitness reimbursement
- Pet insurance options
Schedule:
Day Shift | Monday β Friday
Overtime: As needed
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Apply
Interested CNC programmers can apply directly through hireCNC.
Apply Now or Save This Job to come back later.
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
The Quality Engineer I Quality Operations specializes in Quality Operations, and is responsible for overseeing and improving the quality of manufacturing processes, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives to enhance product quality and customer satisfaction. You will play a key role in ensuring that our manufacturing operations meet the highest standards of quality and efficiency while adhering to relevant regulations and industry best practices.
Job Responsibilities and Essential Duties
- Develop, implement, and maintain quality control processes and procedures for manufacturing operations to ensure compliance with regulatory requirements and industry standards.
- Establish and monitor key performance indicators (KPIs) to assess manufacturing quality and identify opportunities for improvement.
- Participate/ Lead validation and verification activities for manufacturing processes, equipment, and software systems to ensure they meet quality and regulatory requirements.
- Develop/ review validation protocols, execute validation studies, and analyze data to ensure process robustness and reliability.
- Ensures through Design Transfer activities the Device Master Records (DMRs) contents are developed, controlled, and maintained leading to Risk based Manufacturing Control Plans.
- Support/ Investigate and resolve Out of Tolerance events identified during equipment/ instrument calibrations.
- Investigate product nonconformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA).
- Track and monitor CAPA effectiveness to ensure issues are resolved and prevented.
- Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee.
- Implement corrective and preventive actions (CAPAs) to address root causes and prevent recurrence of quality issues.
- Facilitate risk management activities related to manufacturing processes, identifying, and mitigating risks to product quality, safety, and efficacy.
- Implement risk-based decision-making processes to prioritize quality activities and allocate resources effectively.
- Lead and support continuous improvement projects aimed at enhancing manufacturing processes, reducing defects, and optimizing productivity.
- Utilize quality tools and methodologies, such as Six Sigma, Lean Manufacturing, and Statistical Process Control (SPC), to drive process optimization and waste reduction.
- Ensure compliance with applicable regulations, including FDA Quality System Regulation (QSR), ISO 13485, and other international standards.
- Support both internal and external audits as an SME for Production & Process Controls and presents records of activities related to Design Transfer for New Product Development and Design Changes.
Minimum Requirements
- Bachelor's degree in engineering, Science, or other related field is required.
- Six Sigma Green Belt or other applicable certifications are a plus.
- Minimum 1 year experience in Quality or Engineering.
- Experience in a medical device or pharmaceutical industry.
- Experience with Class III disposable and/or Electro-Mechanical medical devices is preferred.
- Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR. Knowledgeable on specific requirements for Design Controls and Risk Management is preferred.
- Knowledge of application & selection of Sampling Plans, to support Risk based Manufacturing Controls Plans.
- Project management and leadership experience is desirable.
- Knowledge of Microsoft Office Products such as Word, Excel, or equivalent software applications.
Required Knowledge, Skills and Abilities
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R).
- Ability to work effectively in a cross-functional team environment.
- Ability to review and understand technical standards and their requirements for products.
- Lead improvement initiatives, either independently or as part of cross-functional teams
The base salary for this the position is a minimum salary of $87,000 and a maximum of $90,000 with 8% annual bonus
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
Job Duration: 10+ months
Job Location: Minnetonka, MN 55345
Job Summary
The client is seeking a highly motivated Project Engineer (Contractor) to support Cardiac Rhythm Management (CRM) New Product Development initiatives. This role will support a senior project lead and is responsible for driving day to day execution of assigned project activities, with a strong emphasis on vendor coordination, material procurement, schedule adherence, and cross functional alignment. The ideal candidate is a self starter who can take ownership of assigned deliverables, work independently with minimal direction, and proactively resolve issues in a fast paced, regulated medical device environment.
Key Responsibilities
- Design, communicate, and execute detailed operational plans to complete assigned project deliverables in support of CRM new product development programs.
- Monitor project progress and performance against defined schedules, milestones, and commitments; proactively identify risks, delays, or resource constraints.
- Take ownership of issue resolution by identifying root causes, driving corrective actions, and escalating when appropriate to minimize schedule and cost impacts.
- Coordinate vendor activities, including:
- Communicating technical and schedule requirements
- Tracking material availability and delivery timelines
- Holding vendors accountable for meeting agreed upon milestones and quality expectations
- Support material procurement activities by interfacing with Supply Chain and external suppliers to ensure timely availability of components and materials required to meet project needs.
- Identify, secure, and coordinate cross functional resources required to execute project tasks, including R\&D, Quality, Regulatory, Supply Chain, and Material Compliance teams.
- Develop and maintain project schedules, task plans, and status reports using established project management tools (e.g., MS Project, Smartsheet).
- Coordinate engineering documentation and project artifacts in compliance with design control, quality system, and documentation requirements.
- Prepare and present clear, concise project updates to stakeholders, including progress, risks, mitigation plans, and upcoming milestones.
- Support design owners by clarifying design intent and technical requirements when interfacing with vendors or cross functional partners, reducing burden on core design teams.
- Participate in meetings and forums as needed to support project execution, issue resolution, and alignment across functions.
Required Qualifications
- Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related discipline).
- 3-5 years of experience supporting engineering or product development projects in a regulated environment.
- Demonstrated ability to manage multiple tasks, priorities, and stakeholders simultaneously.
- Strong communication skills, with the ability to effectively interface with vendors, engineers, and cross functional partners.
- Proven ability to work independently as a self directed contributor, taking ownership of tasks and determining the best path to execution with minimal supervision.
- Working knowledge of project management principles and tools (e.g., MS Project, Smartsheet, or equivalent).
Preferred Qualifications
- Experience in the medical device industry (strongly preferred).
- Familiarity with FDA QSR, ISO 13485, and design control processes.
- Experience coordinating or managing external vendors or contractors, including schedule tracking and delivery accountability.
- Prior exposure to new product development (NPD) programs.
- Ability to operate effectively in environments with ambiguity and evolving priorities.
Success in This Role
- Within the first 6-12 months, success will be demonstrated by:
- Consistent on time delivery of assigned project deliverables
- Positive feedback from project stakeholders and cross functional partners
- Effective management of vendor timelines and material deliveries
- Ability to navigate ambiguity, anticipate issues, and proactively drive solutions
Location: San Diego, CA 92121
Duration: 3+ Months
Job Description:
- Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. Basic level systems knowledge.
- Performs goods receipts against purchase orders or invoices, maintains records of received goods.
- Prepares, verifies and packages goods for shipment. Creates shipping documents for outgoing carriers. Fedex, UPS, DHL etc.
- Restocks supplies, delivers goods to offices.
Must Haves:
Given the small size of our team, which consists of just three people, it's essential to have someone cover Juan's duties to ensure smooth operations. The responsibilities of the temporary replacement will include a variety of critical tasks:
- Packing and shipping both domestic and international QSRs, verifying quantities, MCNs, and necessary paperwork, and processing everything in Precision.
- Handling India Sales Orders by processing them in Corp Oracle, creating all required documents, and ensuring their shipment.
- Running picks for customer sales orders, packing, and shipping them, and generating all necessary paperwork.
- Monitoring emails and the shipping list for sales orders.
- Managing and creating purchase orders for onsite crating services, overseeing the crating of equipment, and handling shipping and related documentation.
- Providing tracking information for outgoing shipments and monitoring the locations of delivered packages.
- Facilitating and managing prepaid orders and vendor prepaid freight shipments.
- Shipping and Receiving
Nice to Have:
Additionally, the temporary replacement will need to manage incoming deliveries and pickups:
- Capturing information and drivers' logs for all incoming deliveries and pickups.
- Maintaining, filing, and storing paperwork properly.
- Receiving and verifying deliveries from SP carriers and freight forwarders, noting any damages, and processing received packages in BEARTRACKS before routing them to end users.
- Monitoring the customer pickup rack, clearing, and delivering items to the office as needed, and prompting recipients to collect packages timely.
- Processing incoming EAG deliveries, emailing recipients, and routing them accordingly.
- Coordinating with third-party vendors and contractors for incoming freight and SP deliveries, routing them as needed.
- Processing and receiving PO inventory and non-inventory orders, verifying quantities and MCNs, and routing them appropriately.
- Receiving QESR orders, verifying quantities and part numbers, and routing them accordingly.
- Working closely with buyers on receipt amendments, damaged goods, reversals, and mis-deliveries.
- Handling blind receipts for drop-shipped items and managing the storage and notification process for Hazmat room items.
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
To support CS Manufacturing and support the manufacturing engineering department.
Job Responsibilities and Essential Duties
- Observes and complies with all safety rules and regulations. This includes QSR and ISO Standards.
- Participates in Material Review Boards (MRB) Decision process.
- Identifies and implements corrective actions for manufacturing related issues.
- Performs equipment setup and corrective, preventative and calibration maintenance as necessary.
- Installs and validates equipment and processes in the production area to improve yield and/or reduce cycle time following the established validation procedure.
- Evaluate operating data to conduct on-line adjustments to products, instruments, or equipment. May develop or revise documents and procedures.
- Certifies manufacturing associates in the production processes.
- Evaluates and orders necessary equipment, tools, and fixtures.
Minimum Requirements
- A high school diploma or equivalent is required. Associate Degree in Engineering, Science or related technical field is preferred.
- One to three years of technician experience in a manufacturing environment is required; Experience working in medical device manufacturing or other FDA regulated industry would be ideal.
Required Knowledge, Skills, and Abilities
- Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
- Must demonstrate effective verbal and written communication skills.
- Must be well organized and demonstrate the ability to work independently and manage multiple tasks and priorities. Must be flexible and demonstrate the ability to take initiative.
- Proficiency with Microsoft Office products such as Word and Excel or equivalent software applications is preferred.
The compensation range for this position is between $26-$31 per hour depending on experience and location.
#LI-MV1
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
Position: Manufacturing Customer Quality, Manager
Department: Manufacturing Quality
Reports To: Director, Manufacturing Quality
Salary Type: Exempt
Location: Philadelphia, PA
Make a greater impact at Bonduelle Americas!
Bonduelle Americas is a certified B Corp inviting people to embrace a flexitarian lifestyle with an expanding portfolio of plant-rich products available in and beyond the produce aisle. We operate four facilities and employ nearly 3,000 Associates in the US.
Bonduelle Americas is a wholly-owned subsidiary of Groupe Bonduelle (BON.PA), an established global brand with more than 170 years of family heritage bringing the joy of plants to tables around the world. Globally, our ready-to-eat plant-rich food products are grown on 173,000 acres by our grower partners and marketed in nearly 100 countries. Our mission is to inspire the transition toward a plant-rich diet to contribute to people's well-being and planet health.
Join us at Bonduelle Americas for an opportunity to advance your career in a culture that places people first. As a valued member of our company, you will work in a mission-driven environment aimed at preserving the planetβs resources while providing healthy plant-based products to millions of consumers around the world.
Position Summary:
The Manufacturing Customer Quality Manager is responsible for leading customer quality performance within the manufacturing environment. This role serves as the primary interface between manufacturing sites and customers on quality-related matters, ensuring customer requirements are understood, implemented, and consistently met. The position drives customer complaint reduction, manages customer audits and scorecards, and leads corrective and preventive actions to protect customer trust and brand integrity.
Reporting to the Director, Manufacturing Quality the Manufacturing Customer Quality Manager owns the day to day customer rejections, customer complaints, consumer complaints, and the corrective action follow through for each of these processes.
Primary Responsibilities:
- Customer Quality Leadership
- Serve as the primary point of contact for customer quality issues related to manufacturing.
- Translate customer quality, food safety, and regulatory requirements into actionable manufacturing standards and practices.
- Advocate for the customer within manufacturing while balancing operational and business needs.
- Customer Complaints & Issue Resolution
- Lead investigation and resolution of customer complaints, including root cause analysis and corrective/preventive actions.
- Ensure timely, accurate, and professional responses to customers in alignment with agreed service level expectations.
- Analyze complaint trends and partner with operations and quality teams to drive systemic improvements leveraging AI and technology to identify trends quickly
- Customer Audits & Scorecards
- Lead preparation for and execution of customer audits at manufacturing facilities as it pertains to manufacturing quality (e.g. meeting customer specifications on quality parameters)
- Coordinate responses to audit findings, including corrective action plans and effectiveness verification as it pertains to manufacturing quality
- Own customer quality scorecards, performance metrics, and continuous improvement plans.
- Serves as the primary subject matter expert for regulatory requirements including, but not limited to: food safety, food defense, labeling, ingredients, formulations, allergens, standards of identity, nutrition, claims, net weight, processing, environmental, regulatory bodies (USDA and FDA), OSHA, EPA, ESG, and social responsibility.
- Manufacturing Quality Systems
- Partner with plant quality and operations teams to ensure robust execution of quality and food safety programs.
- Monitor adherence to customer specifications, process controls, and finished product quality customer requirements.
- Support change management activities, including new product introductions, formula changes, and process modifications.
- Work closely with Manufacturing, Supply Chain, Customer Service, Product Development, and Food Safety teams to align on customer expectations.
- Continuous Improvement & Risk Management
- Use data and KPIs to identify risks and opportunities impacting customer quality.
- Lead or support continuous improvement initiatives focused on defect reduction, right-first-time manufacturing, and customer satisfaction.
- Ensure lessons learned are shared across sites and embedded into standard practices.
Minimum Qualifications:
- BS Degree in Food Science, Quality, or related field.
- 5+ years of experience in quality, food safety, or manufacturing operations within food manufacturing or consumer packaged goods.
- Direct experience managing customer quality issues, audits, and complaint resolution.
- Experience working in a manufacturing environment required.
- HACCP or PCQI certification preferred.
- Strong knowledge of food safety and quality systems, including HACCP, GMPs, and GFSI standards.
- Experience with customer audits, scorecards, and performance management.
- Proven root cause analysis and corrective action expertise.
- Experience supporting major retail or QSR customers preferred
Additional Qualifications:
- Proficiency with standard computer applications (Google Workspace, Microsoft Suite).
- Strong written and verbal communication skills with the ability to influence across functions.
- Demonstrated ability to analyze complex regulatory information and translate it into actionable guidance.
- Proven capability to manage projects end-to-end and drive results in ambiguous or rapidly changing environments.
- Ability to educate, train, and βsellβ compliance programs and continuous improvement initiatives to stakeholders.
- High learning agility and resilience in the face of setbacks or incomplete information.
- Strong conflict management and problem-solving skills grounded in data and process thinking.
- Willingness to flex schedule as business needs require.
- Ability to travel up to 30%.
Job Title:Β Director of Quality Assurance β Tissue Processing
Location:Β San Antonio, Texas, USA
Department:Β Quality Assurance / Regulatory Affairs
Reports To:Β Executive Leadership
FLSA Status:Β Exempt
Position Summary
The Director of Quality Assurance is responsible for providing strategic leadership, direction, and oversight to the companyβs Quality Management System (QMS) to ensure compliance with international and domestic tissue processing regulations, standards, and corporate policies. This role establishes quality strategy, directs organizational compliance programs, and ensures alignment with corporate objectives across all quality assurance processes, including regulatory compliance, internal and external audits, risk management, supplier quality, and continuous improvement initiatives. The Director of Quality Assurance serves as a key member of the leadership team, providing executive-level guidance on quality strategy and regulatory risk management, ensuring the delivery of safe and effective products that meet or exceed customer and regulatory requirements.
Essential Duties and Responsibilities
- Lead the implementation, maintenance, and improvement of the QMS in compliance with cGMPs, ISO 13485:2016, ISO 14971:2019, and FDA 21 CFR:
Part 11 (Electronic Records; Electronic Signatures),Β
Part 820 (QSR)
Parts 361/1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products)
And the relevant FDA Guidance documents for these regulations
- Provide oversight of product release strategy and ensure compliance through delegated authority.
- Establish and oversee policies for raw material acceptance, supplier controls, and product disposition.
- Ensure organizational compliance with labeling and packaging requirements through policy, audit, and review.
- Plan, manage, and resource internal audits, supplier audits, and regulatory inspections; serve as the host and primary point of contact for regulatory and notified body representatives.
- Assure programs related to document control, GMP training program, and controlled record management are in compliance.
- Direct Quality approval for the CAPA process, including nonconformance handling, root cause analysis, corrective/preventive action planning, and effectiveness verification.
- Provide oversight and guidance for product risk management in accordance with ISO 14971.Β Β Perform the quality review function for device pFMEA/dFMEAs and design control through delegation to appropriately trained and qualified staff.
- Review and approve quality-related documentation, including validation protocols, verification reports, design control deliverables, and batch records.
- Develop the key quality metrics for the periodic QMSR (Quality Management Systems Review) to drive systemic improvements, enhancing compliance and operational effectiveness.Β Β
- Develop, mentor, and direct the Quality team and oversee staff development across multiple quality functions to ensure alignment with company goals and regulatory expectations.
- Partner with cross-functional teams (Process Engineering, Manufacturing, Warehouse/Distribution, Regulatory Affairs, Operations, Sales) to support quality throughout the product lifecycle.
- Competency and proficiency in making standard Regulatory submissions, updates, and communications, such as FDA Establishment Registrations, 510kβs, State Registrations, and FSCA for Medical Devices.Β
- Ability to guide the organization to compliantly launch new medical device products and configurations to market
Required Qualifications
- Bachelorβs degree in Engineering, Life Sciences, Quality, or related field; advanced degree strongly preferred.
- Β Minimum of 10β12 years of progressive experience in tissue processing quality assurance, with at least 5+ years in a director-level or equivalent leadership capacity.
- Comprehensive knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971, and EU MDR.
- Demonstrated experience and favorable outcomes with FDA inspections, notified body audits, and supplier quality programs.
- Expertise in QMS software platforms and document control systems.
- Strong analytical, problem-solving, and decision-making skills.Β
- Professional certifications CQA, CQE, LSSBB, or RAC.
Competencies
- Executive leadership and organizational management skills
- Regulatory compliance expertise
- Effective communication and presentation abilities, including executive reporting and Board-level communication
- Strong attention to detail
- Continuous improvement mindset
- Demonstrated ability to mentor and coach staff and peers
Work Environment & Physical Requirements
- This position operates in a professional office and/or manufacturing environment.
- Regular use of computers, phones, and office equipment.
- May require occasional lifting of materials up to 25 pounds.
- Exposure to manufacturing floor environments.
Travel Requirements
- Occasional domestic travel may be required (estimated 20%) to support audits, supplier evaluations, and regulatory inspections.
Compensation &Β Benefits
- Competitive base salary commensurate with experience.
- Performance-based annual bonus eligibility.
- Comprehensive benefits package, including medical, dental, vision, life insurance, and 401(k) with company match.
- Paid time off, sick leave, and company holidays.
- Professional development opportunities and continuing education support.
Responsibilities
- Develop, implement, and maintain the Quality Management System (QMS).
- Plan, conduct, and coordinate internal and supplier audits to ensure compliance with regulatory and accreditation standards (e.g., CLIA, CAP).
- Manage document control, change control, CAPA, nonconformance management, complaint handling, and MDR/Vigilance activities.
- Coordinate proficiency testing programs and analyze results to identify trends and improvement opportunities.
- Ensure all required regulatory licenses and accreditations remain current.
- Maintain quality documentation, SOPs, and laboratory testing procedures.
- Prepare, analyze, and present quality metrics and reports for management review.
- Train and onboard new personnel; review training documentation and monitor ongoing competency of testing staff.
- Maintain working knowledge of laboratory protocols, specimen processing, equipment operation and maintenance, and data analysis.
- Review and approve product labeling, packaging, promotional materials, and technical documentation for regulatory compliance.
- Monitor changes in global regulations, standards, and guidance; assess impact and recommend updates to internal processes.
- Partner with cross-functional teams (R&D, manufacturing, engineering, clinical, marketing) to embed quality and regulatory requirements early in product development.
- Lead or support management reviews, regulatory and quality training programs, and continuous improvement initiatives.
- Prepare, submit, and maintain regulatory filings, documentation, and reports.
- Coordinate with regulatory and accreditation bodies to support product approvals, certifications, and inspections.
- Ensure compliance with internal health and safety policies; report and address violations as required.
- Participate as an external auditor on College of American Pathologists (CAP) inspection teams, as required by the CAP accreditation program.
- Bachelor's degree (required) in life sciences, biology, chemistry, engineering, pharmacy, or related field; Master's a plus
- 3+ years of laboratory experience, including experience with audits, compliance systems, and regulatory submissions.
- Strong knowledge of key regulations and standards: FDA QSR (21 CFR Part 820/211), ISO 13485/9001, EU MDR/IVDR, GMP, ICH guidelines, etc.
- Working knowledge of relevant regulatory frameworks
- Professional certification is a plus (i.e, Regulatory Affairs Certification β RAC, ASQ Certified Quality Auditor β CQA).
- CLS Generalist or CGMBS license preferred
- Proven knowledge of quality assurance terminology, software, methods, and tools.
- Previous experience with Laboratory Information Management Systems is preferred.
- Proficient in QMS software (i.e. MediaLab, TrackWise, MasterControl or similar)
- Strong analytical, problem-solving, and decision-making skills.
- Experience in compliance and/or regulatory and knowledge of laboratory standards and regulations
- Experience with Microsoft Office Suite; Word, Outlook, Excel
- Excellent written and verbal communication skills for agency interactions, technical writing, and cross-functional collaboration.
- Able to effectively present information and respond to questions from various stakeholders
Job Summary:
The Sr. Director of Quality Compliance directs Governance, Audit, Inspection, Escalation and Risk Management and is a valued member of the PAI Quality Leadership team. The incumbent will direct, consult, develop, implement, maintain, and ensure that the overall cGMP compliance profile is maintained effectively. This role will ensure the development and implementation of compliance processes and systems in a manner consistent with global quality systems requirements, corporate standards, current regulatory and client requirements. The role will engage effectively with health authorities and identify mechanisms to assure that our practices and policies meet current regulatory expectations.
The incumbent will direct the quality notification to management program through escalation of quality events and the governing processes. The role will manage the DEA compliance, external and internal audit programs, and CMO audit requirements. The incumbent will lead continuous improvement programs and support compliance and risk activities.
We are seeking an ideal candidate who can establish a Quality Compliance strategy and direction throughout the organization.
The incumbent will work to ensure continuous improvements regarding the most recent national and international cGMP compliance standards and to accomplish compliance in the most efficient way. The position will, develop and lead inspection readiness programs and provide guidance on all compliance related matters. They will advise on industry issues and regulatory changes that may affect PAI. This role involves developing and implementing strategies to ensure compliance with regulatory standards, conducting audits and inspections, and managing quality-related issues to maintain the company's integrity and reputation.
Key Responsibilities:
β’ Develop and implement quality compliance programs and policies.
β’ Conduct internal and external audits to ensure compliance with regulatory standards and company policies.
β’ Quality Compliance and Internal Audit - Directs the activities for conducting internal audits across the Business Unit and manages all external audits by Notified Bodies, FDA, DEA and other Competent Health Authorities.
β’ Oversee inspection processes and ensure readiness for regulatory inspections.
β’ Manage escalation processes to address and resolve quality issues promptly. Notifies executive leadership through corporate quality escalation program.
β’ Direct and Communicate Notification to Management regarding escalated quality events
β’ Collaborate with cross-functional teams to implement quality compliance corrective and preventive actions (CAPAs).
β’ Monitor and review quality assurance and quality control data to identify trends and areas for improvement.
β’ Prepare and maintain documentation related to compliance, audit, inspection, and escalation activities.
β’ Provide training and support to employees on quality compliance and audit practices.
β’ Stay updated on industry regulations and standards to ensure ongoing compliance.
β’ Report to senior management on quality compliance, audit, inspection, and escalation activities and progress.
β’ Post Market Surveillance - Directs the activities to comply with regulatory requirements for post-market surveillance of PAI products on the required schedule for adequacy of product instructions for use, risk management, performance and other key factors.
β’ Compliance and Internal Audit - Directs the activities for conducting internal audits across the Business Unit and manages all external audits by Notified Bodies, FDA, DEA and other Competent Authorities.
β’ Tracks and trends Quality Indicators.
β’ Interfaces with all PAI manufacturing facilities as well as other Business Unit functions.
β’ Executes on Quality Goals as approved by the Quality Leadership Team.
β’ Ensures maintenance all required records for the QMS.
β’ Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department.
β’ Provides leadership for the overall Quality Compliance Escalation & Notification to Management process and associated CAPAs.
β’ Analyzes internal quality systems and associated data to assure adherence to QSRs, DEA, and other international standards (ICH), PAI quality standards, and Business Unit and Facility quality standards.
β’ Develops, reviews and maintains Quality Policies.
β’ Reviews Quality audit reports and prepares appropriate corrective action responses.
β’ Establishes and leads an inspection readiness program. Provides on-site support for inspection management for key inspections.
Qualifications:
β’ Bachelorβs degree in: Pharmacy, Chemistry, Biology, Chemical Engineering, or relevant discipline.
β’ Minimum of 15 years of experience in quality assurance, quality control, or risk management within the pharmaceutical industry at a senior leader level.
β’ Knowledge of systems and processes which support Quality management. Specifically, operational experience in the core QMS processes such as document management, change control, deviation handling, quality control, good distribution practices, supplier quality management, and escalation to management processes.
β’ Demonstrated excellent interpersonal, written and verbal communication skills, and demonstrated ability to prepare written reports, correspondence and presentations to senior leadership.
β’ Experience recognizing the broad, systemic implications of problems and issues and demonstrated experience with negotiating win-win solutions for a broad range of global QMS initiatives.
β’ Comprehensive understanding of auditing principles and ability to perform as a lead auditor. Experience with regulatory authorities from an auditing perspective with regulatory experience in a pharmaceutical GMP environment required.
β’ Knowledge of Quality best practices and experience with technology tools to support the
β’ Extensive knowledge of global quality regulations, industry or international standards and ability to interpret and implement.
β’ Ability to understand Regulatory, Business Unit and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency at the Business Unit & Plant levels.
β’ Ability to interface with regulatory bodies to defend quality compliance.
β’ Proven leadership ability and experience building and maintaining positive relationships globally, both internally and externally.
β’ Broad expert knowledge of pharmaceutical, API, Aseptic, and OTC manufacturing processes and regulations.
Skills & Competencies:
β’ Knowledge, experience, and skills with quality assurance functions; and the use of information technology platforms. Track record of strong involvement with industry professional associations is preferred. Capability to network within the pharma industry and partner strategically with health authorities/regulators.
β’ Industry experience in applying predictive analytics and big data/artificial intelligence to create predictive indicators of quality manufacturing
β’ Capability to collaborate effectively with across global quality network
β’ Listening, negotiating and effective communication skills under pressure are highly preferred. Business minded and customer focused.
β’ Responsible for monitoring sponsored studies for compliance with PAI quality standards, regulatory agencies requirements, and if applicable, global standards/requirements
β’ Ensures that company products meet defined quality standards through management oversight
β’ Directs, initiates, plans, and develops processes and projects to define and implement quality assurance practices within manufacturing operations in line with organizational policies, standards, and guidelines. Ensures overall quality control of processes, raw materials, and products in line with regulatory and industry standards.
β’ Manage Quality and Compliance teams so that Quality Management Systems PAI sites in compliance with all relevant legislation and controls; and relevant guidelines are fully addressed in a way which is relevant to our sector of industry and dosage forms, proportionate, appropriate and sustainable.
β’ Directs and manages audit processes and reporting requirements designed to support the functional area strategies that align with the principles and values of PAI.
β’ Quality Assurance
β’ Quality Risk Management
β’ Quality Compliance Management
β’ Quality Control
β’ Process Improvement
β’ Data Analysis
β’ DEA and DSCSA Standards
PHYSICAL REQUIREMENTS / WORKING CONDITIONS:
β’ The physical requirements and working conditions listed for this job are representative of those required on the job. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities. Typical office environment requiring the use of typical office equipment (e.g., computers, phones, etc.). Computer keyboarding, computer monitor and mouse use including reaching forward, grasping, finger and wrist manipulations, and neck bending and turning: near vision is necessary for computer monitor use. Continuously required to stand, sit, walk, talk and hear, occasionally required to reach with hands and arms, frequently required to stand, sit, walk, talk and hear, occasionally required to reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl. Ability to lift to 30lbs.
β’ PAI is an Equal Opportunity Employer. PAI uses E-Verify.
β’ EEO Employer / Veteran / Disabled
WHO IS 7 BREW...
7 Brew is a rapidly expanding drive through beverage experience with over 600+ locations across 38 states in the US. We are one of the fastest-growing QSR brands in the world, with plans to open more domestic locations in 2026.
We're passionate about crafting delicious and unique beverages while providing a fast and friendly customer experience. We believe in creating a vibrant and energetic work environment where our team members can thrive and grow.
Our mission is to cultivate kindness one tasty drink at a time.
WHATβS BREWING IN THIS ROLE...
The Supply Chain Systems Associate plays a critical role in supporting implementation, optimization, and management of Crunchtime and ArrowStream supply chain systems. This role will be responsible for system integration, data analysis, and process improvements to enhance supply chain efficiency, accuracy, and visibility across the organization.
THE FLAVOR YOU ADD...
- Deployment, configuration, and ongoing maintenance of Crunchtime and ArrowStream supply chain management systems.
- Ensure data accuracy across all supply chain systems.
- Maintain reporting dashboards, data analytics, and KPIs to monitor supply chain performance.
- Optimize supply chain processes through system enhancements, automation, and innovative solutions.
- Coordinate with distributors and first-party partners to resolve system issues, implement updates, and improve functionality.
- Drive continuous improvement initiatives to streamline operations, reduce waste, and improve service levels.
- Manage system documentation, compliance, and audit requirements related to supply chain technology.
MUST-HAVE INGREDIENTS...
Education
- Bachelorβs degree in Supply Chain Management, Business Administration, Information Technology, or a related field.
Experience
- Understanding of supply chain processes, analytics, and automation tools.
- 2+ years of experience with Arrowstream and Crunchtime preferred
Position Title: Senior Project Manager
Location: Houston, TX
About the Company:
Apex Imaging Services is a nationwide custom solution provider for multi-site remodels and rollouts in the retail and restaurant industries. Weβre revolutionizing the commercial multi-site remodel industry at Apex by developing cutting-edge tech and blending it with our team of skilled tradespeople.
About the Role:
The Senior Project Manager is responsible for overseeing and managing construction projects on-site,
ensuring they are completed on time, within budget, and to the required quality standards. This
role involves coordinating various aspects of the construction process, from planning through to
project completion, while managing resources, stakeholders, and contractors.
Knowledge and Skills Required:
- 8+ years of experience in construction
- Experience in fast paced remodel, tenant-improvement, multi-site roll out
- Strong background with Big-Box Retail, QSR/Fast Casual Restaurants
- Ability to manage multiple sites and crews/teams at any given time
- Good understanding of MEP Building Systems.
- Familiarity with Project Management software
Responsibilities:
The responsibilities of the Senior Project Manager include but are not limited to:
- Strategic Project Planning: Develop and deο¬ne project objectives at a strategic level, create comprehensive schedules, set high-level performance requirements, and select key project participants to drive successful execution and alignment with organizational goals.
- Advanced Resource Optimization: Strategically oversee the optimal allocation and utilization of labor, materials, and equipment, ensuring their procurement is conducted under the most cost-effective and advantageous terms.
- Operational Oversight: Lead the implementation of operational strategies through high- level coordination and management, ensuring seamless execution across all phases of the project.
- Executive Communication and Conο¬ict Management: Establish and execute robust communication frameworks and conο¬ict resolution mechanisms to address and resolve issues among project stakeholders effectively and efficiently.
- Complex Multi-Site Management: Direct and manage multi-site construction projects from inception to completion, ensuring integrated execution and alignment with strategic objectives.
- Comprehensive Planning and Budget Oversight: Spearhead strategic planning and budgeting efforts, including high-level resource identiο¬cation and allocation, to ensure projects are executed in line with organizational goals and ο¬nancial constraints.
- Leadership in Team Development: Formulate and lead project teams, set strategic objectives and goals, and delegate responsibilities to drive project success and enhance team performance.
- Strategic Project Accounting: Oversee all project accounting functions, including budget management, expense tracking, and risk mitigation, ensuring ο¬nancial integrity and accountability.
- Schedule Enforcement: Ensure rigorous adherence to project schedules, making strategic adjustments as needed to accommodate changes and maintain project timelines.
- Dynamic Work Plan Development: Develop and continuously reο¬ne project work plans to address evolving needs, ensuring adaptability and responsiveness to project demands.
- High-Level Contractor Coordination: Manage and direct communication with contractors across various project phases, ensuring timely, high-quality completion and alignment with project requirements.
- Stakeholder Integration: Coordinate and integrate efforts among all project stakeholders, including architects, consultants, contractors, subcontractors, and internal resources, to ensure cohesive project execution.
- Strategic Progress Monitoring: Monitor and evaluate construction progress at a strategic level, conducting executive status meetings with sub-teams to review performance, address issues, and drive project success.
- Compliance and Quality Assurance: Enforce strict adherence to budgetary guidelines, quality standards, and safety regulations, ensuring projects meet or exceed all regulatory and organizational requirements.
- Documentation Oversight: Ensure comprehensive management of all project documentation, maintaining accuracy and completeness to support effective project management and compliance.
- Dispute and Claim Management: Proactively identify and address potential sources of disputes and claims in project design and construction, implementing effective resolution strategies to mitigate risks.
- Senior Client Liaison: Act as the primary senior liaison with clients, reviewing and approving deliverables prepared by the project team to ensure they meet or exceed client expectations before ο¬nal submission.