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Job Title: Director of Quality Assurance – Tissue Processing
Location: San Antonio, Texas, USA
Department: Quality Assurance / Regulatory Affairs
Reports To: Executive Leadership
FLSA Status: Exempt
Position Summary
The Director of Quality Assurance is responsible for providing strategic leadership, direction, and oversight to the company’s 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),
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. 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.
- 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, 510k’s, State Registrations, and FSCA for Medical Devices.
- Ability to guide the organization to compliantly launch new medical device products and configurations to market
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Quality, or related field; advanced degree strongly preferred.
- Minimum of 10–12 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.
- 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 & 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.
Manufacturing Engineer – Advanced Detector Systems
Location: Sturbridge, MA (100% Onsite)
Salary: Up to $140K depending on experience
Environment: ISO 7 Cleanroom, High‑Voltage/High‑Vacuum Equipment
Candidates with backgrounds in semiconductor fabrication, vacuum systems, photonics, electron‑optical components, or high‑voltage instrumentation are strongly encouraged to apply.
Position Summary
We are seeking a hands‑on Manufacturing Engineer to support electrical testing, troubleshooting, and production of advanced detector technologies, including microchannel‑based devices and electron‑multiplying components. This role is highly technical and hardware‑focused, requiring daily work on the production floor within an ISO 7 cleanroom.
You will ensure detector assemblies meet stringent electrical, vacuum, and performance specifications while supporting test station operations, conducting full detector teardowns, and maintaining test capability during high‑priority manufacturing periods. This position also plays a key role in transitioning from manual testing to more automated systems.
What You’ll Do
Electrical Testing & Data Integrity
- Perform electrical testing on detector components using high‑vacuum systems (10⁻⁷ to 10⁻⁶ Torr).
- Maintain test stations and ensure data accuracy and traceability.
- Identify and escalate anomalies in test results.
Troubleshooting & Failure Analysis
- Diagnose electrical, mechanical, and vacuum‑related issues in detector assemblies.
- Conduct full mechanical and electrical teardowns.
- Investigate failure modes such as low gain, shorts, contamination, vacuum leaks, alignment issues, or component damage.
Manufacturing Support
- Work directly with cleanroom operators to resolve production issues quickly.
- Update work instructions, procedures, and test documentation.
- Train operators and new engineers on testing, teardown, and handling methods.
- Support yield improvement and scrap‑reduction initiatives.
- Track, analyze, and report yields, scrap rates, and defect trends.
- Provide day‑to‑day support across multiple product lines; occasional off‑shift work may be required.
Process Control & Continuous Improvement
- Use MINITAB for basic SPC, trend analysis, and yield monitoring.
- Support the transition from manual to semi‑automated test equipment.
- Identify opportunities to improve test repeatability, throughput, and data capture.
- Contribute to Lean Manufacturing, 5S, and SPC implementation.
- Promote adherence to ISO 9001‑based quality systems.
Equipment & Fixture Support
- Maintain and configure high‑voltage power supplies, vacuum controllers, electrometers, oscilloscopes, and custom fixtures.
- Assist in modifying fixtures or creating temporary setups to maintain production continuity.
Required Qualifications
- U.S. citizenship (required due to ITAR regulations).
- Bachelor’s degree in Engineering (Electrical, Mechanical, Materials, Physics, or related field).
- Hands‑on experience with high‑voltage systems, high‑vacuum equipment, precision instrumentation, or cleanroom operations.
- Strong mechanical aptitude and comfort working directly with hardware.
- Ability to troubleshoot electrical and mechanical issues methodically.
- Strong technical communication skills—written and verbal.
- Proficiency with MS Office, MRP systems, databases, and analytical/statistical tools.
- Ability to work full‑time onsite in an ISO 7 cleanroom environment.
- Willingness to learn specialized detector physics and test methods.
Preferred Qualifications
- Background in semiconductor, photonics, vacuum systems, electron optics, or detector technologies.
- Experience with SPC tools, MINITAB, or basic statistical analysis.
- Familiarity with high‑voltage power supplies, vacuum chambers, turbopumps, or electrometers.
- Experience assembling or disassembling delicate electro‑mechanical components.
- Understanding of gain behavior or noise mechanisms in electron‑multiplying devices (e.g., PMTs, MCPs, avalanche detectors).
Work Environment
- 100% onsite in a high‑tech manufacturing facility.
- ISO 7 cleanroom requiring gowning, gloves, and contamination‑control procedures.
- Work involves high‑voltage and high‑vacuum equipment; full safety training provided.
- Standard day shift with occasional support needed for urgent production issues.
- PPE such as safety glasses, gloves, and hearing protection may be required.
We put the unity in "opportunity."
Opportunity Snapshot:
- Compensation: $49.00/hour
- Location: Port Neches, TX
- Assignment Duration: 6 months+
- Work Schedule: Monday-Friday, hybrid, 40 hours +
- Benefits: Comprehensive with 401K, holidays and PTO
Qualifications:
- Bachelor's degree in Chemistry or Chemical Engineering required
- 5-7 years of experience in Environment Compliance
- Experience quality compliance
- Experience in leading and conduction audits, both internal and external
- Knowledgeable in GMP Standards
- Must possess knowledge in some of the following (EXCiPACT, FSSC22000, BRCGS, ISO 9001, etc)
Responsibilities:
- Develop and manage the execution of the Validation Master Plan. Make changes to Validation plans and programs. Develop validation protocols.
- Investigate system NCRs and root cause failure analysis
- Develop and manage audit schedules. Coordinate internal and external audit scopes, objectives and availability. Oversee audit execution and compliance
- Manage the updating and generation of procedures and protocols for the validation of equipment, systems, and/or processes
- Manage local Quality Management system. Product Safety Management
- Authority to stop any product or service that puts at risk the quality, legality, or safety of the products, as well as any activity that puts at risk the physical integrity of people, the environment, and/or facilities
- Determine the appropriateness and effectiveness of actions to close non-conformities
- Define KPIs and their criteria with a continuous improvement approach and governance
- Update and control the Document Management System
- Promote, influence, and ensure compliance with the Quality and Safety Management System
- Develop cleaning and CCP (Critical Control Points) validations
- Maintain current quality certifications, executing actions based on risk analysis, potential and real nonconformities, and seeking continuous improvement
- Implement new quality certifications aligned with business strategy
- Ensure that the quality and safety requirements of the products and production processes are met, adhering to standards and policies (ISO 9001, ISO 22716, ISO 14001, ISO 45001, RSPO, BRCGS, EXCiPACT, FSSC2200, EFfCI, Kosher, Halal, etc.)
- Implement GMP practices applicable to Quality Assurance
- Develop initiatives and programs to promote quality standards. Develop and deliver training
- Manage budget and process invoices
- Support other functions in QA-related aspects or inquiries
The Bergaila Way:
The Bergaila Companies is a nationally recognized leader in providing staffing services to all sectors of the energy industry. We continually focus on partnering with talented professionals, engineering the perfect fit between our clients and employees. Choosing a career path with Bergaila grants you immediate access to nationally recognized organizations we partner with. Bergaila consistently attracts and retains its Employees with our dedicated internal service team, top tier benefits programs for contractors and their families, and commitment to place you in the desired career of your choice.
Client Overview:
Our Client is a global industry leader in the creation of indispensable chemistry that benefits billions of people worldwide. Among other products, our client creates safe and durable packaging for foods and beverages, pharmaceuticals, cosmetics and technical polymers that benefit multiple industries.
Based in Tyrone with some travel across Europe
Large scale wind, solar and Data Centre projects
Salary €85,000 + Vehicle + Bonus + Pension + Healthcare + International Project Exposure
The Company
We are working with well established contractor operating across the European renewable energy and industrial sector, delivering large scale wind, solar, battery storage and data centre projects. With a strong pipeline of work across Ireland and mainland Europe, they are recognised for delivering complex energy infrastructure projects safely, efficiently and to the highest quality standards.
Their growth is driven by the increasing demand for renewable energy and sustainable infrastructure. With projects spanning multiple jurisdictions, they place a strong emphasis on safety leadership, environmental responsibility and best practice across every stage of project delivery.
The Role – Health & Safety Manager
The Health & Safety Manager will take ownership of the company’s HSE strategy across Ireland and Europe, supporting multiple renewable energy construction projects including wind farms, solar developments, battery storage, grid infrastructure and data centres.
Working closely with the Managing Director and senior leadership team, you will lead the development and implementation of best in class health and safety systems while ensuring full compliance with Irish and EU legislation. This is a senior leadership role focused on driving a strong safety culture across multiple sites, improving reporting frameworks and ensuring that all projects operate to the highest safety standards.
You will work closely with project managers, engineers and site teams across Europe, providing guidance on risk management, audits, incident investigations and regulatory compliance while supporting the continued expansion of the company’s renewable energy portfolio.
Key Responsibilities
- Lead and implement the company’s HSE strategy across renewable energy projects in Ireland and Europe
- Ensure compliance with Irish and European health and safety legislation including Construction Regulations, PUWER, LOLER and associated directives
- Manage and maintain HSE management systems including ISO 45001 and ISO 14001 across all project locations
- Carry out internal and external HSE audits and ensure corrective actions are implemented effectively
- Provide guidance to project teams on RAMS, risk assessments, permit to work systems and safe work planning
- Drive a positive safety culture across project teams and subcontractors with a focus on behavioural safety
- Develop and maintain HSE performance reporting and KPIs across multiple European projects
- Lead incident investigations, root cause analysis and continuous improvement initiatives
- Deliver training and mentoring for site managers, engineers and supervisors on key safety topics
- Liaise with regulatory authorities, certification bodies and project stakeholders during inspections and audits
- Support environmental and sustainability initiatives including waste management and environmental risk controls
- Produce monthly and quarterly safety performance reports for senior management and project stakeholders
About You
- Chartered IOSH member CMIOSH or equivalent qualification such as NEBOSH Diploma or MSc in Occupational Health and Safety
- 8 to 10 years experience in health and safety within construction, utilities, power generation or renewable energy projects
- Strong background working on wind farms, solar farms, battery storage or grid infrastructure projects is highly desirable
- Experience managing health and safety across multiple sites and jurisdictions within the EU
- Proven experience implementing and managing ISO 45001 safety management systems
- Excellent knowledge of Irish and European health and safety legislation and compliance requirements
- Strong leadership and communication skills with the ability to influence teams at all levels
- Experience leading audits, incident investigations and safety improvement programmes
- Comfortable working across multiple sites with regular travel across Ireland and Europe
- Practical, solutions focused approach to risk management and safety leadership
What’s on Offer
Salary: €85,000 (review after 6 months)
Benefits:
• Company vehicle
• Performance related bonus
• Pension
• Health insurance
• Phone and laptop
• Professional development support including IOSH, NEBOSH and ISO auditor training
• Travel expenses and flexible working arrangements
• Opportunity to work on large scale renewable energy projects across Europe
Why Apply?
This is an excellent opportunity for a senior Health and Safety professional to take ownership of HSE strategy within a growing renewable energy contractor operating across Ireland and Europe. The role offers significant influence at leadership level while working on some of the most important energy infrastructure projects currently under development.
With strong growth in wind energy, solar power, battery storage and grid infrastructure across Europe, this position offers long term career development in one of the fastest growing sectors in construction and energy.
How to Apply
If you’re interested in this role, contact Breagh Recruitment on or send your CV to for a confidential discussion.
Why Breagh Recruitment?
Breagh Recruitment specialise in recruiting Health & Safety Managers, HSE Managers and Safety Leaders for construction, engineering and renewable energy projects across Ireland and Europe.
If you are considering a move within the renewable energy sector or looking for a new Health & Safety Manager opportunity within wind farms, solar farms, battery storage or power infrastructure projects, Breagh Recruitment can help you identify the right role with leading contractors and developers.
INDCO
At Bosch, we shape the future by inventing high-quality technologies and services that spark
enthusiasm and enrich people’s lives. Our areas of activity are every bit as diverse as our outstanding
Bosch teams around the world. Their creativity is the key to innovation through connected living,
mobility, or industry.
Let’s grow together, enjoy more, and inspire each other. Work #LikeABosch
• Reinvent yourself: At Bosch, you will evolve.
• Discover new directions: At Bosch, you will find your place.
• Balance your life: At Bosch, your job matches your lifestyle.
• Celebrate success: At Bosch, we celebrate you.
• Be yourself: At Bosch, we value values.
• Shape tomorrow: At Bosch, you change lives.
Job Description
The Quality Engineer ensures product integrity, compliance, and customer protection within the Distribution Center by maintaining strict control of nonconforming product, leading investigations for customer complaints related to shipping errors or transportation damage andsustaining the ISO 9001:2015 Quality Management System.
The role drives corrective and preventive actions, supports internal audits, strengthens logistics processes, and promotes a culture of quality ownership across warehouse and shipping operations.
Product Nonconformance Management
- Maintain the identification, segregation, documentation, and disposition of nonconforming product within the DC.
- Ensure no nonconforming product is shipped without formal approval.
- Track trends in damages, mislabels, and packaging issues.
- Shipping errors
- Missing or incorrect items
- Packaging failures
- Transportation damage
- Apply structured problem-solving (8D, 5 Why, Ishikawa).
- Define and follow up on corrective actions with Operations, Logistics, and Carriers.
- Communicate complaint status and risks to internal stakeholders.
- Maintain DC-specific procedures, work instructions, and records.
- Coordinate internal audit schedules and support external audits.
- Ensure document control and compliance with ISO requirements.
- Plan and execute internal audits for receiving, storage, picking, packing, and shipping.
- Document findings and ensure timely closure of corrective actions.
- Validate adherence to Standard Work and packaging standards.
- Implement Lean tools (5S, standardization, Poka-Yoke, Kaizen) in warehouse processes.
- Analyze data to reduce:
- Shipping errors
- Transportation damage
- Rework and repacking
- Cost of Poor Quality (COPQ)
- Support cross-functional improvement projects.
- Lead root-cause analysis for internal defects and customer complaints.
- Validate effectiveness of corrective actions through data and audits.
- Identify risks in packaging, labeling, handling, and storage processes.
- Train warehouse personnel on:
- Defect detection
- Packaging standards
- Escalation processes
- Handling of nonconforming product
- Promote quality ownership across all shifts.
Required Qualifications
- Bachelor’s degree in engineering
- Experience in manufacturing quality, process engineering, or related technical roles.
- Knowledge of ISO 9001 Quality Management Systems.
- Proficiency in problem-solving tools (8D, 5 Why, Ishikawa, A3 etc.).
- Ability to read and interpret technical drawings and specifications.
- Strong analytical, communication, and cross-functional collaboration skills.
- Experience in HVAC, automotive, or high-volume manufacturing environments.
- Knowledge of APQP, PPAP, PFMEA, Control Plans, MSA, and SPC.
- Experience with supplier defect notifications
- Lean or Six Sigma certification (Green Belt preferred).
Additional Information
Equal Opportunity Employer, including disability / veterans
*Bosch adheres to Federal, State, and Local laws regarding drug-testing. Employment is contingent upon the successful completion of a drug screen and background check. Candidates who have been offered the position must pass both screenings before their start date.
Your well-being matters at Bosch! We offer a competitive compensation and a benefits package designed to empower you in every area of your life. This includes premium health coverage, a 401(k) with generous matching, resources for financial planning and goal setting, ample paid time off, parental leave, and comprehensive life and disability protection. We're investing in your success!
#LI-CB1
At Tundra Testing, precision is our mission, and as a Laboratory Manager, you'll lead the charge in ensuring every sample meets the highest standards of accuracy and reliability. You'll be at the helm of our operations, guiding a team of skilled technicians in an environment where precision and accountability are second nature. Your expertise in running efficient and compliant laboratories will align our processes with rigorous ISO/IEC 17025:2017 standards. We're seeking someone who thrives on leadership and process improvement, ready to manage resources and streamline workflows to deliver analytical data that drives smarter decisions.
At Tundra Testing, we foster a culture of discipline, accountability, and service, combining cutting-edge technology with our expertise to support vital industries. Here, professional growth is encouraged, and your impact is significant and valued. If you're ready to take on a role that empowers you to make a difference, let's make strides together in our mission-driven laboratory. Join us in our commitment to precision, respect, and unwavering integrity.
$115,000 yearly
Responsibilities:- Lead and mentor a team of laboratory technicians, fostering a culture of precision and accountability.
- Oversee daily laboratory operations, ensuring compliance with ISO/IEC 17025:2017 standards.
- Develop and implement efficient workflows to optimize laboratory processes and resource management.
- Ensure the accuracy and reliability of all test results, maintaining the highest standards of quality.
- Collaborate with cross-functional teams to drive continuous improvement and innovation in laboratory practices.
- Manage laboratory budgets and resources, ensuring cost-effective operations without compromising quality.
- Conduct regular audits and inspections to ensure compliance with safety and regulatory requirements, protecting both staff and community health.
- Education: Bachelor’s degree in Chemistry, Environmental Science, Biology, or related field (advanced degree preferred).
- Experience: Minimum 5 years in laboratory management or supervisory leadership within an environmental, analytical, or materials testing lab.
- Strong working knowledge of ISO/IEC 17025:2017, QA/QC systems, and analytical method traceability.
- Excellent leadership skills with a focus on mentorship, accountability, and high-performance culture.
- Proficiency in laboratory safety management, including OSHA, NIOSH, and Alaska DEC standards.
- Experience with LIMS platforms, data integrity, and audit documentation.
- Exceptional communication and problem-solving skills, with the ability to balance technical detail and operational oversight.
At Tundra Testing, precision isn’t just a promise — it’s our mission. We’re a Veteran-led, Alaska-owned environmental and materials testing laboratory based in Anchorage, strategically located near Ted Stevens International Airport to shorten the distance between sample and solution.
Our team delivers defensible, compliance-ready data for soil, water, air, and biological materials using EPA-approved, ISO/ASTM/NIOSH-validated methods. We support Alaska’s most vital industries — oil and gas, construction, real estate, and environmental development — with a focus on speed, transparency, and regulatory confidence.
Driven by a culture of discipline, accountability, and service, we combine cutting-edge technology with local expertise to produce results that meet or exceed federal and state standards. Every analysis, every report, and every client relationship reflects what we stand for: respect, precision, and unwavering integrity.
#WHGEN2
Compensation details: 115 Yearly Salary
PI61adeae210d8-37344-39988442
This role is accountable for rapid, compliant problem resolution across sites while also driving longer-term capability building, standardization, and quality system maturity.
Manage people, projects, and priorities to address resource and operational challenges.
Direct and manage sites during FDA inspections and responses to observations.
Liaison with site operation management providing input and support to ensure Quality and Compliance requirements are being met.
Partners cross-functionally with manufacturing, engineering, regulatory, operations, corporate quality, to increase regulatory compliance.
Support Quality Systems related activities, analyze problems related to quality/regulatory information, and provide process structure and technical support in solving these problems.
Provide expertise, counsel and guidance to Quality leadership.
Manage the Quality data integrity for Medline products including but not limited to, sterile products, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements.
Job Description MAJOR RESPONSIBILITIES Lead personnel, activities, and resources for continuous Quality System improvement.
Motivate and engage the team and others around the operational excellence vision and ensure execution.
Advises leadership to ensure the QMS for assigned departments are in compliance as measured by FDA/ISO/internal audits.
Collaborate with cross-functional teams to deploy quality processes and systems.
Consult and provide guidance to business partners.
Partners with other applicable leaders to ensure a strategic approach to any regulatory audit and related responses.
Partners with other applicable leaders to ensure a strategic approach to any regulatory audit and related responses Prepare and deliver Customer presentations Oversee critical Quality systems projects and team that identify, lead and drive opportunities to improve quality systems and develop long-term strategies that support the success of the business.
Review and determine the application of various system compliance regulations.
Ensure compliance to global regulatory requirements with internal procedures.
Identify risk and compliance opportunities.
Train and coach personnel and cross-functional teams to deliver optimal results.
Management responsibilities include: Typically manages through multiple Managers Provide leadership and management to one or more major departments of an operating unit or to a department that has systemwide accountability Strategic, tactical and operational planning (12 + months) for the function or department Direct budgetary responsibility for one or more departments, functions or major projects/programs Interpret and execute policies for departments/projects; develop, recommend and implement new policies or modifications to existing policies Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies MINIMUM JOB REQUIREMENTS Education Bachelor’s degree in technical or scientific discipline Work Experience Knowledge of Food and Drug Administration (FDA), Quality System Regulations (QSR) and International Organization of Standardization (ISO).
Proficiency in Microsoft Suite.
Position requires travel up to 20% of the time for business purposes (within state and out of state).
Knowledge / Skills / Abilities Job Title: Sr Dir Quality Systems Job Code: 62398 MINIMUM JOB REQUIREMENTS Experience leading people and cross functional teams through quality change and continuous improvement.
Experience hosting FDA/ISO GMP inspections and regulatory meetings.
Experience writing, reviewing, and managing FDA responses Experience with quality systems development and implementation.
Experience with Medical Device Design Controls, CE technical File Requirements, and 510K submissions.
Experience in the Medical Device, Pharmaceutical industry, cosmetic, combination product industry.
Experience hosting FDA/ISO GMP inspections.
Proficiency in analyzing and reporting data to identify issues, trends, or exceptions to drive improvement of results and find solutions.
Demonstrated ability to control and coordinate team priorities, concurrent projects, competing priorities and critical deadlines.
Position requires travel up to 25% of the time for business purposes (within state, out of state and/or internationally).
PREFERRED JOB REQUIREMENTS Work Experience 8 years or more of managerial experience preferred.
10 years or more of related experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products industries preferred.
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position: $203,000.00
- $305,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities.
This role is bonus and/or incentive eligible.
Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
For a more comprehensive list of our benefits please click here .
For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career.
We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best.
Explore our Belonging page here .
Medline Industries, LP is an equal opportunity employer.
Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
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.
JobOverview
The Staff Engineer, Sustainabilityleads sustainability initiatives across product development, operations, and supply chain whileestablishinggovernance frameworks. It ensures measurable environmental impact reductions, compliance with FDA/ISO standards, and trusted performance metrics aligned with business strategy.
Job Responsibilities and Essential Duties
Drive carbon reduction roadmap and eco-design principles.
Lead lifecycle assessments and integrate sustainability into product development.
Collaborate with suppliers on low-carbon initiatives.
Support compliance with ISO 14001, ISO 14040, and FDA standards.
Ensure raw material complianceto include RoHS, REACH, EU MDR Prop65
Define and standardizegovernance & KPI'sacross teams.
Ensure data integrity and consistent reporting.
Build dashboards to track sustainability and performance KPIs.
Review and updategovernanceto align with evolving strategies.
MinimumRequirements
Degree in Engineering, Sustainability,Project Management,or Data&Analytics.
7+years in sustainability, governance, or regulated environments.
Knowledge of lifecycle assessment, ISO frameworks, and BI tools (Power BI, Tableau).
Strong communication, stakeholder management, and analytical skills.
PMP Certification a plus.
Salary range: $98,000.00 - $125,000.00 plus bonus targeted at 10% (depending on overall company performance)
#LI-LG1
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.
Avantor | NuSil is looking for a Quality Control Supervisor to join our team supporting manufacturing of high-purity silicone products. In this role you will provide leadership, technical, and strategic guidance, supporting quality operations for chemical manufacturing in an ISO 9001 and AS9100 certified environment.You will also drive and engage with continuous improvement activities to support the QC lab and overall business objectives.
This role will be a full-time, 2nd shift: 3:00pm - 11:30pm, onsite position based out of our Carpinteria, CA facility.If you are a transformative leader seeking an exciting opportunity to drive quality initiatives - let's talk!
What we're looking for
- Education: High School completion or equivalent (GED) is required; Bachelor's degree in Biology, Biochemistry, Chemistry or science related field is highly preferred
- Experience: 3 years of related/applicable lab or manufacturing experience is highly preferred
- A proven leader, in a manufacturing and QC lab environment, that can contribute to maturing Quality functions, systems and risk-based processes to achieve business objectives
- A quality, compliance, and business minded individual that values a growth mindset, partnerships, and collaboration
- Excellent communication, interpersonal and people management skills
- Demonstrated knowledge on the application of regulated quality and production risk-based processes
- Strong analytical and problem-solving skills
- Collaboration Tool: Familiarity with MS Office (Word, Excel, Access)
- Preferred Qualifications:
- Minimum 1 year of supervisory experience and/or leading a team
- Preferred experience in quality systems, quality assurance, and quality control
- Experience with a regulated ISO 9001 and/or AS9100 manufacturing environment
How you will thrive and create an impact
- Directly supervises the quality control staff, monitor individual skills and abilities for most efficient operation; follow progress of work; anticipates or investigates delays of inadequate performance; take corrective action within limits of established practice; aid other departments as needed.
- Provides on the floor and technical support to quality control associates
- Support and enforce the quality system, regulatory policies and work instructions.
- Maintain quality and quantity of output; arrange for equipment, materials and supplies to be available for work assignments; see that equipment is given proper care; troubleshoot faulty operations to determine cause and arrange for required repair and maintenance.
- Provide or arrange for training and cross-training to employees in the performance of duties; assist and instruct personnel as necessary to insure proper flow of work through department.
- Provide guidance to all level Technicians including test methods, analytical technique, good laboratory practice, paperwork completion, equipment, schedule interpretation, and LIMS support.
- Review and approval of controlled Quality Control documents including but not limited to: specifications, procedures, work instructions, validation protocols and validation reports.
- Ensure department documents and procedures are up to date and reflect current practice; revising procedures & processes when needed.
- Performs investigations for laboratory out of specification results, safety related incidents and/or processes related to the QC laboratory.
- Work with customers, regulatory agents and vendors during audits and site visits.
- Understands regulatory requirements for 21 CFR820, ISO 17025, EXCiPACT, GLP, GMP including USP/EP general practices and procedures.
- Proactively maintains current industry and regulatory knowledge for medical devices, ISO 17025, GMP principles and current analytical technology.
- Assist in determining priority of urgent items and appropriate action plan to effectuate priority.
- Approve rejections and rework actions as recommended by Quality Control Technicians.
- Enforce prescribed safety rules and regulations; insure that work areas are maintained in a neat and orderly condition; perform safety and security procedures to open and close buildings and facilities.
- Performs other duties as assigned.
KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
- Strong interpersonal and organizational skills
- Ability to work in a team environment
- Ability to identify and resolve issues
- Strong decision making skills
- Ability to lead a team and provide guidance
- Strong attention to detail
- Strong communication skills
ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)
Typically works in a lab environment with adequate lighting and ventilation and a normal range of temperature and noise level. At times, may be exposed to a variety of different chemicals including flammables, corrosives, oxidizers and others.
Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
A frequent volume of work and deadlines impose strain on routine basis.
Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.
#LI-Onsite
Disclaimer:The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.
Why Avantor?
Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!
Pay Transparency:
The expected pre-tax pay for this position is
$86,000.00 - $138,000.00Actual pay may differ depending on relevant factors such as prior experience and geographic location.
EEO Statement:
We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
For more information about equal employment opportunity protections, please view the Know Your Rights poster.
3rd Party Non-Solicitation Policy:
By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.
Build a Career That Matters with One of the World's Most Respected Employers!
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Mission :Operates independently and cooperates with other Central Metrology Technicians to guarantee precision, dependability, and adherence to established standards for calibrations within Central Metrology Lab Scope.
Calibration: Check, analyze, and recalibrate measurement devices based on established criteria, maintaining accurate readings.
Documentation: Maintain clear, detailed logs of laboratory standards, calibration procedures, test findings, and maintenance carried out to follow quality management systems and external guidelines (e.g., ISO 17025).
Process improvement: Partner with fellow Central Metrology Technicians and Internal Business Partners to advance metrology practices and calibration protocols, spot opportunities for progress, and carry out solutions.
Training: Provide training and guidance as needed to other technicians and internal business partners on metrology and calibration techniques and standard methodologies.
Troubleshooting: Detect and address inconsistencies in process and procedures by conducting root cause analysis.
Works autonomously and collaboratively with other Central Metrology Technicians to ensure precision, reliability, and conformity to defined standards for calibrations within the Central Metrology Lab Scope.
Calibration: Assess, test, and calibrate measurement devices following established standards, maintaining accurate readings.
Documentation: Carefully and thoroughly record all laboratory standards, calibration processes, test outcomes, and maintenance to meet quality management systems and external criteria (e.g., ISO 17025).
Process improvement: Work alongside other Central Metrology Technicians and Internal Business Partners to advance metrology techniques and calibration procedures, detect areas needing improvement, and apply solutions.
Training: Deliver instruction and mentorship as required to other technicians and internal business partners regarding metrology and calibration techniques and standard processes.
Troubleshooting: Detect and address inconsistencies in processes and procedures by conducting root cause analysis.
Key encouraged achievementsAdhere to safety protocols and procedures, including the use of personal protective equipment (PPE).
Perform calibrations on a wide range of measuring devices using precision measuring instruments and software, ensuring environmental controls in the lab are adequate before performing calibrations. Detect and communicate any measurement/calibration nonconformities to all interested parties.
Record and document test results, maintenance performed, and any deviations or non-conformities in calibration logs, records, and certificates, ensuring traceability and adherence to quality and regulatory standards.
Coordinate and arrange the servicing of devices alongside other Central Metrology Technicians to enhance lab operational efficiency. Use organizational and time management abilities to handle workloads and schedules efficiently.
Assist in the development and/or update of calibration procedures and documentation in accordance with National, International, or Industry Standards.
Provide technical aid and advice to colleagues and Internal Business Partners.
Technical Skills:> Perform calibration of various parameters of gauge types, as approved by procedure training, evidence of competency, and maintaining individual uncertainties in alignment with other calibration technicians
- Dimensional - Hand tools, Hard gauges, Surface Plate Flatness etc.
- Mechanical- Pressure, Vacuum, and Torque
- Electrical - Multimeters, Thermocouples and RTD's
- Chemical - Refractometers, pH Meters, and Conductivity meters etc.
- Sound level meters, Belt tensioners etc.
- Vision Systems
- Coordinate-measuring machine (CMM)
> Strong knowledge of measurement science (metrology)
- Understand contributors and variables that influence the development of an uncertainty budget.
> Ability to read and interpret technical manuals, blueprints, schematics and diagrams
> Knowledge of electronics and engineering principlesEngage in Intra-laboratory and external laboratory Proficiency tests as needed. Not passing Proficiency tests may lead to corrective or preventative measures, including remedial training and/or restriction from calibrating certain types of gauges.
Soft Skills:Attention to detail: Meticulous and precise, with a focus on accuracy.
Problem-solving: Strong analytical skills for troubleshooting and resolving complex issues
Computer skills: Proficiency with calibration software and other computer-based test equipment
Communication: Ability to clearly communicate technical information and work effectively in a team. Collaborate with Plants regarding processes, procedures, and corrective/preventative actions, when gauges are found to be out of tolerance.
Understanding of standards: Experience with quality and regulatory standards (e.g., ISO 17025, ISO 9001)
Associate degree or Certificate from a technical school or military training
Measurement & Metrology / Machine Tool Technology / CalibrationASQ Certified Calibration Technician Certification is a plus.
#li-eo2Ready to Shape the Future of Innovation?
Michelin is building a world-leading manufacturer of life-changing composites and experiences. Pioneering engineered materials for more than 130 years, Michelin is uniquely positioned to make decisive contributions to human progress and a more sustainable world. Drawing on its deep know-how in polymer composite materials, Michelin is constantly innovating to manufacture high-quality tires and components for critical applications in demanding fields as varied as mobility, construction, aeronautics, low-carbon energies and healthcare.
The care placed in its products and deep customer knowledge inspire Michelin to offer the finest experiences. This spans from providing data- and AI-based connected solutions for professional fleets to recommending outstanding restaurants and hotels curated by the MICHELIN Guide.
Why Michelin?
Career Growth: Personalized development plans, mentorship, and cross-functional opportunities. Unique career paths and opportunities for advancement.
Inclusive Culture: Thrive in a diverse, supportive environment where your competencies, contributions and behaviors are recognized. Option to join one of our Connected Communities.
Innovation-Driven: Work on projects that matter-from sustainable materials to digital transformation.
Community Impact: Be part of a company that does what's right. We use sustainable business practices while balancing the needs of our customers and communities.
Michelin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors. Consistent with these obligations, Michelin also provides reasonable accommodations to employees and applicants with disabilities and for sincerely held religious beliefs. If you need accommodation for any part of the employment process because of a disability, please contact us at .
This position is not available for immigration sponsorship.
We build the future with people like you. Begin your career with Michelin today!