Engineering Jobs in Allendale, NJ

We are a full-service fire alarm & suppression supply and service company based in Riverdale, NJ for over 25 years.

Our company is one of the largest fire protection companies offering high quality industrial and commercial fire protection systems and services.

We are seeking a new Estimator to join our rapidly growing Estimating Team.

In this role, you will include compiling any and all information needed to complete a takeoff, building a bill of material that best covers the scope of work, and generating comprehensive proposals that clearly state the scope of work covered in our pricing.

As a member of the Estimating Team, you will consult with the Engineering department, Field engineers, Project Managers, and other Estimating Team members to discuss and formulate estimates and resolve issues and report directly to the Estimating Manager.

The Estimator is responsible for the following: · Analyze blueprints, specifications, and technical documents to gain a thorough understanding of the project in order to prepare time, cost, materials, and labor estimates.

· Partner collaboratively with cross-functional teams (design engineering, Productions, Sales, finance, etc.) to understand requirements and ensure alignment to scope, schedule, and budget.

· Build a project Binder that consists of all documentation used to complete a take-off.

· Generate a proposal that includes the labor and materials needed to cover the scope of work gained from a completed take-off.

Why You Will Love Us: As part of the Specialized Fire & Security Estimating Team, you will be provided with the best tools for the job with the latest in computer technology and support.

Our Estimators act with passion to use our collective skills and knowledge to create a better experience for each individual on the team.

We pride ourselves as being the on the front lines when it comes to making sure we have a project completely covered for our clients, their clients, and for the entire Specialized Fire & Security family.

Compensation details: 24-40 Hourly Wage PI92b0da7c916

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

Effectively design, develop, and document medical devices and medical equipment that satisfy internal and external customer needs and business objectives.

Job Responsibilities and Essential Duties

* Interprets customer specifications to define requirements for mechanical designs.

* Performs first principal analysis related to appropriate aspects of mechanical design.

* Provide support to peers, Jr Engineers, and Co-Ops.

* Applies the 3D CAD system to create mechanical design and drawings.

* Develops detailed fabrication and assembly drawings and performs tolerance analysis.

* Develop prototypes for design evaluation.

* Troubleshoot and resolve design & processing issues.

* Contributes to details of design documentation using electronic documentation systems.

* Collects, analyzes, and interprets data to propose recommendations.

* Develops & execute design verification protocols and technical reports.

* Work with internal and external resources on fabrication, inspection, and testing of new product parts and assemblies.

* Develop & debug prototype tooling / equipment and processes.

* Develop test methods and fixtures.

* Formulate plans & methods to accomplish assignments with appropriate oversight.

* Works independently and prioritizes assigned tasks with guidance.

* Contribute to project planning activities.

* Train technicians and operators on new process techniques.

Minimum Requirements

* BS in engineering discipline, mechanical preferred.

* Minimum 2-4 years related experience, or an MS and less than one year experience.

* Experience with a solid modeling CAD program, preferably SolidWorks and/or ProE.

* Experience in medical equipment / device design with experience in electromechanical, electro- pneumatic, and/or blood pumping equipment development.

* Knowledge in medical device industry regulations and practices - ISO 13485, ISO 7198 & GMP.

* Proficiency with Microsoft Windows, MS Office applications, and Adobe Acrobat.

* Experience with Microsoft Visio and Microsoft Project preferred.

Required Knowledge, Skills, and Abilities

* Design for Manufacturability and Assembly, DFM&A (cost/tooling/process considerations), preferably using SolidWorks CAD software.

* Understanding in design and development of injection molded plastic, plastic extrusion, casting, sheet metal, metal stampings, additive manufacturing processes, and machined metal components, and assemblies with high part counts highly desirable.

* Knowledge of mechanical design and development using metric ANSI/ISO dimensioning and drafting standards highly desirable.

* Understanding of GD&T, mechanical measurement and testing equip., and statistical analysis of test data.

* Experience with electronic document control systems in medical device and/or medical equipment design and development.

* Highly skilled at analytical reasoning, mechanism design, creative problem solving, and mathematical analysis.

* Ability to create and meet scheduled timelines (manage and coordinate tasks as required).

* Ability to work in a team environment.

* Strong communication skills.

* Competent in use of Microsoft Office tools.

* Ability to operate test equipment such as various pressure and flow measurement equipment, temperature/humidity chambers, PC-based data recorders, simulators, DVM's and oscilloscopes.

* Familiarity and the ability to operate basic shop equipment such as hand tools, a drill and Dremel.

* Understand and interpret simple wiring diagrams.

* Familiarity with Agile Scrum and waterfall project planning methods

This is a "Defined Term" assignment that will last approximately 6 months or until project is complete. Defined Term employees are eligible for most benefits (including health insurance and paid time off) while on assignment.

#LI-AS1

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
  

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.

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 Manager, Collagen Operations serves as the sole site leader for the Mahwah, NJ Collagen facility and carries full responsibility for all site personnel decisions, site performance, and operational escalations. This role ensures the safe, compliant, and efficient operation of the site while driving a strong culture of quality, engagement, and continuous improvement.

This position is accountable for the implementation of operational strategy as defined by the Getinge France (La Ciotat) leadership team. The Manager must ensure that all production activities adhere to U.S. regulatory protocols, including FDA, ISO, GMP, ESD, and Medical Device requirements, while also ensuring that all U.S. people practices (HR, safety, compliance, labor standards) are fully adopted and consistently upheld.

The Manager leads the site in achieving production, safety, quality, and delivery objectives while ensuring strong communication, alignment, and reporting back to the Getinge France entity.

Key Responsibilities

Site Leadership & Escalations

Serve as the highest-ranking leader on-site, responsible for daily operational oversight.

Act as the primary escalation point for all personnel, safety, compliance, and operational matters.

Maintain a proactive presence on the production floor; ensure alignment between site activities and La Ciotat leadership direction.

Lead all site-level communication, engagement efforts, and leadership routines.

Safety, Quality & Compliance

Serve as the site owner for safety, quality, and environmental compliance.

Ensure strict adherence to all U.S. regulatory requirements, including FDA, ISO, GMP, ESD, environmental, and medical device standards.

Ensure all U.S. people practices-including investigations, corrective action processes, documentation, training standards, and HR compliance-are consistently applied.

Guarantee timely and effective management of nonconformances, CAPAs, and deviations; lead site-level reviews and escalations.

Operations Management

Lead the execution of the annual production plan and ensure on-time delivery in alignment with customer needs and La Ciotat directives.

Oversee production scheduling, resource planning, inventory management, and staffing decisions.

Ensure production equipment, cleanroom environments, and facilities are properly maintained and audit-ready.

Manage manufacturing engineering and support functions to drive continuous improvement, cost savings, and process optimization.

Ensure documentation accuracy and compliance, including SOPs, controlled documents, training records, and batch documentation.

People Leadership

Full responsibility for all site personnel management, including hiring, onboarding, development, coaching, performance management, and employee relations.

Drive a culture of engagement, teamwork, and accountability consistent with Getinge values and U.S. people practices.

Set clear objectives, oversee workload planning, conduct performance reviews, and support career development.

Cross-Functional & Global Collaboration

Collaborate closely with the La Ciotat Production Director and France-based teams to ensure alignment on operational execution, reporting, and strategy.

Partner with U.S.-based HR, Quality, EHS, Engineering, and Supply Chain teams to ensure compliance and best practices across all site functions.

Coordinate validation, feasibility builds, technical projects, and operational readiness with sustaining engineering and global partners.

Essential Duties

Organize and manage site production resources to meet daily, weekly, and annual plans.

Anticipate operational needs and align staffing with forecasts.

Define short-term production plans compatible with demand and capacity.

Lead investigations into deviations, failures, or operational issues and implement corrective actions.

Oversee preventive and corrective maintenance and technical shutdowns.

Submit and manage investment requests to support operational goals.

Ensure all personnel comply with safety rules, gowning, cleanroom regulations, and quality protocols.

Maintain readiness for internal and external audits at all times.

Minimum Requirements

High school diploma required; advanced education preferred.

3-5 years of experience as a production manager in medical device or similarly regulated environment.

Experience in cleanroom or controlled environment operations preferred.

Demonstrated ability to lead teams and run a manufacturing site with a high level of autonomy.

Strong computer skills; SAP experience a plus.

Targeted salary range: $138,000- $145,000, depending upon experience and location +15% bonus target

#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.

CoWorx Staffing Services has a Direct Hire opportunity for a Supply Chain Manager position in the Northvale area. It is a great opportunity to work with a company that envisions a future of electrification and innovation and strives to create an inspiring workplace where their employees are integral to shaping that future.

Job Summary: We are seeking a Supply Chain Manager to join our clients team in Northvale, NJ. This role will be responsible for managing the complete Supply Chain process including Customer Service, Production Panning, Materials Planning and Ordering, Logistics, and Warehouse function for their automotive products factory.

Main Responsibilities

• Manage a diverse team through coaching, performance management, and development

• Oversee department heads for warehouse, materials, and customer service and support their strategy and execution

• Responsible for on time delivery to customer

• Coordinate the S&OP process

• Manage and execute the demand (customer service) and production plan for a 24/7 production operation

• Drive for zero material shortage and production continuity

• Maintain inventory accuracy and control

• Create a balanced inventory and working capital optimization strategy and execute through team directives

• Handle escalated customer delivery issues

• Implement continuous improvement strategies to eliminate waste and create efficiencies

Qualifications

• Bachelor’s Degree in Supply Chain, Engineering, or Business preferred

• Minimum of seven years of supply chain experience in a manufacturing industry

• Experience of managing a supply chain team

• Extensive demand planning, capacity planning, and production planning experience.

• Experience in stamping or molding operations is a plus

• Comfortable working on-site 100%

• Hands-on style leadership in all supply chain function

Working directly with and mentored by senior managers, Senior Operations Analyst uses analytics to solve cross-functional strategic problems and drives process improvement throughout the organization. He/she will work with manufacturing, product development, merchandising, sales and installation teams to identify and root-cause major operation issues and suggest projects to improve quality, logistics, operations and customer experience. Senior Operations Analyst must have strong analytical and problem-solving skills, good communication skills and the ability to work cross-functionally with high level of self-autonomy. Growth opportunities into senior operating and leadership roles.

Key Responsibilities:

• Work with senior management to identity, analyze and solve systemic business problems
• Analyze all internal communications (plant support office, sales team, customers, etc.) to identify key issues requiring process improvement
• Evaluate operations procedures and processes
• Identify organizations inefficiencies and areas for improvement and redesign
• Root-cause and develop potential solutions to most reoccurring problems; develop and confirm hypothesis using analytics and leveraging experiences
• Communicate recommendation to key managers and leaders and push for changes needed to drive improvements
• Track and facilitate process improvements working across functional groups
• Proactively develop and maintain effective working relationships with and between all departments
• Works at the appropriate levels in the organization to implement strategies and plans

Key Requirements:

• BS/MBA from accredited university in statistics, business, operations research, industrial engineering or related fields
• 3-5 years operations
• Five to ten years of relevant experience including:
• Minimum three years as analyst in consumer, retail or manufacturing business
• Operating experience in manufacturing or consumer business
• Experience using data for root-causing cross-functional business problems
• Leadership – able to use data to influence others and drive change
• Strong skills in Microsoft Excel, Access, Tableau or similar
• Knowledge of SQL or similar software strongly preferred
• Demonstrated communication skills (written and oral)
• Deep process orientation and strong problem solver
• Able to multitask, prioritize, and manage time efficiently
• Excellent verbal and written communication skills

We will invest the necessary time to set the Senior Operations Analyst up for long-term success at BTG. Actual plan will be customized to the individual but will include time to learn the business (retail and manufacturing) and to develop the important internal relationship and trust needed to successfully grow into this leadership role.

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:

This position performs installation, maintenance, and repairs of computer driven electro-mechanical production equipment, ensuring that all related quality documentation is executed, while reviewing maintenance procedures for effectiveness.

Job Responsibilities and Essential Duties:

* Maintenance and repair of computer driven electro-mechanical manufacturing equipment in support of medical device production.

o Computer driven systems include proportional-integral-derivative (PID) operating controllers, programmable logic controllers (PLCs), and Human Machine Interface (HMI) automation.

o Sub-systems and components include electric drives, motors, electrical wiring, hydraulics, pneumatics, electrical panels, relays, printed circuit board circuitry, vacuum, and compressed air.

* Respond to emergency repair requests through troubleshooting, diagnosis, resumption of operation, and electronic documentation.

* Execute preventative/scheduled maintenance including planning of materials, parts, training, and other requirements to ensure work is executed in an efficient and timely manner.

* Document all work planned and performed in the computerized maintenance management system.

* Evaluate operation of equipment and instruments to conduct on-line adjustments. * Evaluate, quote, and order necessary replacement equipment, tools, and fixtures. * May develop or revise documents and procedures.

* Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Minimum Requirements :

* A high school diploma or equivalent is required. An associate degree or equivalent years of experience in Engineering, Science or related technical field is preferred

* 1-3 years of technician experience in a manufacturing environment is required; experience working in medical device manufacturing or other FDA regulated industry preferred.

Required Knowledge, Skills, and Abilities :

* Ability to read wiring diagrams, schematics, and plumbing diagrams to expertly troubleshoot electro-mechanical equipment, electric drives, motors, basic wiring, hydraulics, and pneumatics is required.

* Working knowledge of flow controls, valve selection, and pressure regulation.

* 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.

* Working knowledge of equipment powered by 120, 208/230, and 480VAC electrical voltage is required.

* Experience with PLC/HMI and MS-DOS programming languages is preferred.

* Proficiency with Microsoft Office products such as Word and Excel or equivalent software applications is preferred.

The pay for this role is a minimum of $25 per hour ($52k/yr) and a maximum of $33 per hour ($68,640/yr).

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.

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 Complaint Engineer I conducts complaint investigations to identify causes of reported product defects. The role analyzes complaint data to detect undesirable trends and performs escalation request to drive effective corrective actions. It collaborates crossfunctionally to support timely resolution of product issues and support corrective and preventive actions.

Job Responsibilities and Essential Duties

• 
  
• Perform complaint investigations to determine potential cause(s). This includes evaluating field-reported information, reviewing applicable risk assessments, instructions for use (IFU), trend data, and other relevant documentation. The primary goal is to determine possible failure mechanisms and contributing factors related to the reported issue
  
• Initiate, own and support Corrective and/or Preventive Actions
  
• Perform daily, weekly, monthly data analysis of complaints to identify adverse trends
  
• This is not an inclusive list of job responsibilities
  

Required Knowledge, Skills and Abilities

• 
  
• Bachelor's degree in biomedical engineering, Mechanical Engineering, Electrical Engineering, or related technical discipline.
  
• Minimum of 1 year experience in complaint handling and complaint investigations for medical devices.
  
• General understanding of Good Manufacturing Practices, good Documentation Practices FDA regulations, and ISO requirements.
  
• Experience with Complaint, Corrective and Preventive Actions, Field Actions processes.
  
• Experienced with handling Biohazard materials.
  

• 
  
• Experience with laboratory work in the medical devices industry.
  
• Proficient in Microsoft Office Suite (Power Bi, Excel, Word, Outlook)
  
• Excellent written and verbal communication skills.
  
• Strong problem-solving skills and a passion for investigation and root cause analysis
  
• Strong interpersonal skills.
  
• Good organizational skills. Must be able to adhere to timelines.
  
• Basic understanding of statistical analysis.
  
• Basic understanding of quality systems
  

The base salary for the position is a minimum salary of 85,000 and a maximum of 90,000, plus 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.

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.

About Us

Imagine the innovation and expertise behind the world’s leading cosmetic brands, brought to you by a distinguished Italian company with a legacy of excellence. Since 1972, Intercos Group has been at the forefront of color cosmetics, pencils, nail polish, skincare, and personal care products. We pride ourselves on being the only cosmetics manufacturer that combines top-tier quality and advanced technology with a global reach and a personalized touch.

With 15 commercial offices and 15 production facilities across 12 countries, Intercos Group brings a local approach to a global stage. We continually set the standard for beauty, crafting exceptional product lines for brands worldwide. As one of the largest suppliers in the cosmetics industry, we are a leading force in the research, development, and production of beauty products, shaping the future of the industry with every season.

Position Summary

The Quality Control Manager is responsible for all aspects of Quality measurement, product inspection and in-process testing in West Nyack, NY. The primary responsibility is to ensure that Quality Control personnel perform the required inspection accurately and as specified by the appropriate quality documentation. This position will allocate resources to efficiently maintain orders on schedule.

Essential Functions

• Quality Control – Product Inspection and Release

1. Testing of materials required to produce a finished product and the final product to confirm compliance to issued specifications.
2. QC Inspectors are responsible for (but not limited to)
3. Physical – Dimensions, Hardness, Drop test, tap test, net weight; Visual – Color (e.g. color matching), Appearance; Sensory - Odor, Texture

• Product Disposition

1. Determine final disposition of all products
2. Responsible for approving and rejecting all batches
3. Management of Product Hold and Disposition

• Quality Control Documentation/Samples for Clients

1. Conversion of Product Specifications to Production Line Documentation (checklists, forms)
2. Finished Product Documentation to be issued to Clients, (e.g. COA)
3. Pre-Shipment Samples to Clients

• Management of Documents and Product Samples Retention Requirements

1. Records /Documentation review and sign off for OTC Products

• Monitor and Confirm production operations conforming to specifications or requirements

1. Line Clearance
2. Critical Process Parameter Line Set Up

• Management of Staff
• Manage QC work schedules; accountable for QC team’s work hours
• Responsible for allocating QC personnel to the production line
• Perform staff performance evaluation
• Responsible for the training of the QC personnel, the discipline and morale of the staff.
• Perform other duties and projects as assigned.

Job Qualifications

• Bachelor’s degree in Applied Sciences or Engineering (e.g., Biology, Chemistry, Physics, or a related field).
• At least 5 years of experience in Quality Management, QA, or QC.
• Proven expertise in Quality Management in cosmetic industry
• Familiarity with Quality Systems, including GMP and GLP, in an FDA-regulated industry.
• Strong critical thinking and problem-solving skills, with the ability to identify and resolve issues promptly, analyze information effectively, and develop alternative solutions.
• Excellent interpersonal and communication skills.
• Capable of managing and developing staff.
• Collaborative team player.
• Self-motivated and proactive.

Job Benefits

Health Insurance: Comprehensive medical, dental, and vision coverage

Retirement Plans: 401(k) plan, often with company matching

Life Insurance: Coverage for employees in the event of death or disability

Paid Time Off (PTO): Vacation days, sick leave, and personal days

Holidays: Paid company holidays and floating holidays

Professional Development: Training programs and opportunities for career advancement

Performance Bonuses: Annual merit increase and/or bonus based on individual performance

Company Events: Team-building activities, social events, and company outings

Employee Assistance Programs (EAPs): Confidential counseling and support services for personal and professional issues.

EEO

Intercos Group is committed to creating a diverse and inclusive workplace where everyone is valued and respected. We believe that a wide range of perspectives and experiences enhances our innovation and success. We are an Equal Opportunity Employer and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other legally protected status. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to any of these characteristics. We are dedicated to providing a work environment that is free from discrimination and harassment and promotes equal opportunity for all.

Overview

We are seeking a Maintenance Manager to lead engineering and maintenance operations across multi-site CPG food manufacturing facilities. This role oversees 15 to 25 employees and requires strong plant-level leadership experience in refrigerated, frozen, or fresh food environments.

Key Responsibilities

• Oversee plant facilities, utilities, and equipment maintenance
• Implement structured work order planning and CMMS processes
• Manage MRO inventory and parts storeroom operations
• Ensure reliability of electrical and automation systems
• Lead capital projects using disciplined methodologies
• Drive TPM, RCM, predictive maintenance, and continuous improvement initiatives
• Develop and lead maintenance teams

Qualifications

• 7+ years of maintenance leadership experience, including CMMS, TPM, RCM, and predictive maintenance
• 5 to 7 years in CPG food manufacturing, preferably refrigerated, frozen, or fresh products
• 1 to 3 years of operations supervision
• Strong plant, facility, and operational focus
• Proven capital project leadership experience

Additional Requirements

• Bilingual English and Spanish required (Spanish-speaking workforce)
• Maintenance project management certification preferred
• Experience in meat or dairy manufacturing a plus
• Knowledge of USDA and FDA regulations
• Proficiency in ERP, CAD, and related systems
• Understanding of food processing technology and continuous improvement methodologies

NTG Staffing is seeking a Manufacturing Engineer for a company in Northvale, NJ. This is a direct hire opportunity. The company is seeking a candidate with specific experience in injection molding or metal stamping. Must be local to be considered.

Overview

• Responsible for designing, implementing, and optimizing manufacturing processes to improve efficiency, reduce costs, and maintain product quality.
• Uses production data analysis, process improvements, and technology implementation to support operational excellence.
• Collaborates cross-functionally with engineering, production, and quality teams to ensure successful product launches and ongoing manufacturing performance.

Key Responsibilities

• Improve manufacturing efficiency by analyzing workflows, equipment layout, and facility space utilization.
• Monitor and control manufacturing costs, including labor, materials, and production expenses.
• Identify process improvement opportunities and implement solutions to reduce waste and increase productivity.
• Develop and enforce quality control procedures to ensure products meet established standards.
• Lead pre-launch activities such as prototype, pilot, and validation builds to ensure smooth transition to full production.
• Partner with engineering, design, and production teams to achieve operational and manufacturing goals.

Core Qualifications

• Bachelor’s degree in Engineering or related technical field.
• Minimum of 3 years of Manufacturing Engineer experience.
• Automotive industry experience preferred.
• Strong analytical skills with ability to interpret production data and drive improvements.
• Proven problem-solving skills related to manufacturing processes.
• Strong organizational skills, attention to detail, and ability to meet deadlines.

Electrical Contractor located in Northern Bergen County, NJ seeking a full-time Estimator/Project Manager for commercial projects varying in size throughout the NYC and Tri-State Areas.

ROLE OVERVIEW

• Interpret job bid instructions, technical specifications, and architectural construction prints that are necessary in creating accurate electrical pricing for projects.
• Maintain and log incoming/outgoing bids and meet the deadlines for providing pricing to customers.
• Process and distribute critical/technical information and procured material to the labor force actively building projects.
• Preparation and maintenance of RFI/CO logs over the course of an active project.
• Full-time, in person role
• Work hours: 7:00am – 4:30pm

REQUIREMENTS AND QUALIFICATIONS:

• Four-year degree minimum.
• Degree in engineering/construction is a plus.
• Prior experience in the construction industry is a plus.
• Interest in the Construction and Project Management Field.
• Familiarity with Accubid, AutoCAD, and Bluebeam software is a plus.
• Strong mathematical, mechanical, and technical aptitude.
• An interest and passion for problem solving as it relates to real life construction projects.
• Organizational skills, time management, and willingness to learn are required.
• Must have good communication skills to effectively engage in project meetings with other subcontractors, general contractors, and design professionals.
• Should have strong confidence in speaking either on the phone or in person on a regular basis to vendors, customers, and labor force.
• Must be self-motivated and be able to follow through with a project/estimate from beginning to end with intensity, passion, and pride for their own work.
• Be dependable, self-motivated, and able to function independently with little supervision.
• Enjoys the challenges of an intense, creative, and fast paced industry with opportunity for self-made growth.
• Fluent in English.
• Not a fit for those with a desire to be involved with engineering/architecture design.

BENEFITS:

• Medical - Company pays 75%
• Dental – Company pays 50%
• Life – Company pays 50%
• Holidays
• Vacation
• 401k
• Profit sharing

About us:

We’re Five Star Millwork — a fast growing millwork & trim work company based in Pearl River, NY, with a reputation for exceptional craftsmanship and attention to detail. From high-end millwork to custom kitchen installations, we take pride in delivering work that’s built to last. Our sister companies, Master Trimmer and Five Star Kitchen Design Center, work hand-in-hand to bring beautiful residential and commercial spaces to life.

The Role:

We're looking for an Estimator with specific finish carpentry experience who is ready to work in a fast-paced culture. The Finish Carpentry Estimator will be responsible for all aspects of preparing hard bid construction cost estimates. Responsibilities include plan take-offs, estimating, proposal preparation, negotiations, pre-construction coordination, client relations, and bid tracking. If you are a self-motivated Estimator with sound judgement, strong communication/interpersonal skills, and confidently develops accurate construction bids then we would love to hear from you! Ideally, you will possess knowledge in construction means and methods, costs, and engineering principles to hit the ground running.

The Responsibilities:

• Read and interpret project documents, understand project logistics, understand project schedule, and develop scopes of work.
• Perform detailed and accurate quantity takeoffs and obtain material pricing.
• Work with Five Star Millwork LLC management and field operation teams to estimate labor production rates, identify project efficiencies, and identify alternate approaches.
• Attend client pre-bid meetings, visit project sites, take notes, and assess site-specific conditions.
• Submit and follow up pre-bid requests for information.
• Prepare bids itemized by specification section and detailed into labor, material, equipment, subcontractor, and overhead costs.
• Present bids to management, succinctly explaining estimate details and project specifics.
• Prepare accurate and competitive hard bid construction cost estimates and submit formal proposals in a timely manner.
• Maintain detailed and orderly project files, adhering to Five Star Millwork quality standards.
• Follow up on bid results.
• Build relationships with clients, contractors, and vendors.
• Perform pier reviews of estimates and proposals. Troubleshoot and resolve estimate issues.
• Maintain past performance databases and spreadsheets.
• Research data on industry standard labor production rates and material costs.
• Maintain the bid board, bid tracking logs, customer history, and material management.
• Identify and recommend improvements to the bidding process.
• Maintain professional & technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.

What you bring:

• Bachelor’s degree in Engineering, Architecture, Construction Management, or 10 years’ experience carpentry construction.
• Strong interpersonal and communication skills with the ability to develop and maintain a business relationship with clients and vendors.
• Experience estimating commercial and residential carpentry projects that include finish carpentry, and doors.
• Knowledge of applicable codes and standards.
• Experience with estimating takeoff software.
• Experience estimating construction projects $10,000 to $5,000,000.
• Proficient in Microsoft Windows, Word, Excel, PlanSwift and Quickbooks.
• Superior written and oral communication skills.

Benefits:

• Casual yet professional environment
• Competitive pay
• Paid vacation and holidays
• A yearly review
• Co-workers you enjoy working with

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 primary responsibility for the Sustaining Engineer II position focuses on Design Verification and Validation activities, supporting testing for regulatory submissions, CAPA execution, writing and executing Test Method Validations, and working with component suppliers. This position will report to the Sustaining Engineering Manager.

Job Responsibilities and Essential Duties

• 
  
• Write and execute protocols, such as Design Validations or Verifications. Compile, analyze and report protocol test data.
  
• Write and execute Test Method Validations. Compile, analyze and report testing data.
  
• Update Design Specifications, Risk Management Plans and Reports, FMEAs, or other risk management documents.
  
• Investigate and plan CAPA activities
  
• Communicate and Coordinate activities with other Getinge sites and outside component suppliers.
  
• Implement documentation changes as needed. (Engineering specifications, change notices, manufacturing procedures, and other documentation).
  
• Comply with Quality System Procedures, Good Lab Practices, and Exposure Control Plan.
  
• Develop processes, methods, tooling, and production controls; supervises their assembly and proofing.
  
• Prepares presentations reflecting the status and results of projects.
  
• Lead small projects that support product enhancement and cost savings opportunities.
  
• This is not an inclusive list of job responsibilities.
  

Minimum Requirements

• 
  
• Bachelor of Science degree (or equivalent), preferably in Biomedical, Mechanical or Manufacturing Engineering with 3-6 years of related experience.
  
• General understanding of Good Manufacturing Practices, FDA regulations, and ISO requirements.
  
• Experience with process and equipment validations/qualifications.
  

Required Knowledge, Skills and Abilities

• 
  
• 
  
  • 
    
  • Experienced with laboratory physical testing methods Validation/Verification
    
  • Process Validation/Verification
    
  • Knowledge with the following systems: CAPA, Risk Management, Design Controls and Change Management
    
  • Must have strong technical and analytical ability; detail oriented.
    
  • Must have good verbal and written communication skills.
    
  • Strong interpersonal skills.
    
  • Good organizational skills. Must be able to adhere to timelines.
    
  • Knowledge of computer skills including, but not limited to: Microsoft Windows, Word, Excel, Project, PowerPoint, Teams, Solidworks
    
  • Basic understanding of statistical analysis.
    
  
  
  

Salary range: $94,000.00 - $97,000.00

#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.

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 Project Manager will be responsible for the leadership of complex cross-functional projects related to the development and/or sustainment of electro-mechanical medical device systems and/or single use catheters. Project assignment is at the discretion of the supervisor and is based on business requirements. Also responsible for all phases of the project, from Concept Development to Product Launch. Develop and drive project timelines, assemble required project teams, track schedule and deliverables, and maintain effective communication throughout the project.

Job Responsibilities and Essential Duties

• 
  
• Lead cross-functional project teams in support of Class I - III medical devices.
  
• Monitor and maintain awareness of new and current product regulations and standards.
  
• Develop and release all project-related deliverables, including project plan, schedule and budget.
  
• Manage a project within standardized methods and project models such as Waterfall or Agile
  
• Lead and support execution of technical and/or cross-functional project work
  
• Ensure the timely release of critical deliverables within the project.
  
• Ensure all aspects of the project are in compliance to internal procedures.
  
• Develop and present periodic status reports.
  
• Effective communication with project stakeholders, local management, and global management
  
• Demonstrate leadership when facing uncertainty.
  

• 
  
• Understanding of group dynamics to influence team members and lead the project.
  
• Instill confidence through leadership and actions.
  
• Identify, support, and promote new concepts and initiatives related to Project Management within the organization.
  

Minimum Requirements

• 
  
• BS in Engineering discipline (e.g., Systems, Biomedical, Electrical or Software Engineering) or equivalent experience
  
• Minimum of 3+ years in project lead role or project management role
  
• Preferred - experience in medical device or other regulated industry.
  
• Domestic and/or international travel up to 20%
  

Required Knowledge, Skills and Abilities

• 
  
• Experience with Microsoft Project, JIRA, Antura or other project management software
  
• Experience in leading tasks/projects through a structured, phase-gate process
  
• Lead and manage technical meetings with cross-functional members.
  
• Excellent interpersonal, verbal, and written communication skills
  
• Strong technical writing skills; must be well organized, detail oriented.
  
• Task oriented and driven to complete assignments on schedule.
  
• Must have the ability to effectively interface with both technical and non-technical personnel.
  
• Medical Device experience including thorough understanding of Medical Device Quality Management Systems (ISO 13485, 21 CFR 820, ISO 14971)
  
• Working knowledge of FDA and International Standards requirements as related to capital equipment and disposables.
  

Salary range: $120k - $140k

#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.

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 Responsibilities and Essential Duties

• 
  
• Lead and govern design-related CAPA activities across the R&D organization, ensuring timely, compliant, and effective resolution of complex design, verification, validation, and product performance issues.
  
• Oversee and review root cause investigations using rigorous, data-driven problem-solving methodologies, and ensure corrective and preventive actions are appropriately scoped, risk-based, sustainable, and effectively linked to design controls, risk management, and product lifecycle processes.
  
• Ensure CAPA records and documentation are complete, accurate, and audit-ready, in compliance with FDA regulations, ISO 13485, and internal quality system requirements.
  
• Manage and develop the R&D CAPA team, including setting expectations, prioritizing
  
• workload, providing technical direction, and coaching CAPA specialists and engineers.
  
• Provide technical guidance, coaching, and mentorship to R&D engineers and CAPA owners on CAPA processes, best practices, timeline development, SOP adherence, and effectiveness verification planning.
  
• Serve as the primary R&D CAPA interface with Quality, Regulatory Affairs, Operations, and other cross-functional partners to address systemic and cross-product issues.
  
• Review and approve CAPA plans, timelines, effectiveness verification strategies, and closure rationales to ensure regulatory robustness and high-quality outcomes.
  
• Support internal and external audits, inspections, and assessments by providing CAPA documentation (e.g., CAPA storyboards), investigation rationale, and subject matter expertise.
  
• Act as a CAPA subject matter expert within the R&D organization, driving continuous improvement in CAPA execution quality and consistency.
  

Minimum Requirements

• 
  
• Bachelor's degree in Engineering or related technical field; advanced degree preferred.
  
• 6+ years of experience in R&D within a medical device organization with at least 5 years of CAPA processes and regulatory compliance requirements (FDA, ISO 13485).
  
• 2+ years of leadership experience managing engineering teams.
  
• Proven experience in managing CAPA for design and development activities
  

Required Knowledge, Skills and Abilities

• 
  
• Expert-level understanding of CAPA methodologies, root cause analysis tools (Fishbone, 5 Whys, FMEA), and risk management.
  
• Strong leadership and team management skills with ability to influence and drive accountability.
  
• Excellent analytical and problem-solving abilities with attention to detail.
  
• Effective communication and presentation skills for all organizational levels.
  
• Experience with drafting statistically sound sampling plans & acceptance criteria for measuring Effectiveness of implemented actions.
  
• Proficiency in documentation and electronic CAPA systems, Trackwise preferred.
  
• Deep knowledge of medical device regulations and design control requirements.
  

Salary range: $145k - $175k

#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.

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.

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 Sr. R&D Engineer - CAPA Specialist is a senior individual contributor responsible for leading complex, design and/or R&D controlled QMS process related Corrective and Preventive Action (CAPA) investigations within the Research & Development organization. This role drives robust root cause analysis, corrective and preventive action development, and effectiveness verification to ensure product quality, regulatory compliance, and continuous improvement in design and development processes.

Operating with a high degree of autonomy, this position serves as a technical authority and trusted advisor to R&D teams, providing guidance on structured problem-solving, CAPA best practices, and regulatory expectations. While the role does not include people management responsibilities, it plays a critical mentoring and coaching role within the R&D CAPA ecosystem.

Job Responsibilities and Essential Duties

• 
  
• Lead and execute product design and or Design Controls process related CAPA investigations within the R&D organization, from problem definition through implementation and effectiveness verification.
  
• Perform thorough and structured root cause analyses for design, verification, validation, and product performance issues using appropriate analytical tools and data.
  
• Develop and drive robust corrective and preventive actions that are risk-based, technically sound, and aligned with design controls and risk management processes.
  
• Ensure CAPA documentation is accurate, complete, and compliant with FDA regulations, ISO 13485, and internal quality system requirements.
  
• Collaborate closely with cross-functional partners-including Quality, Regulatory Affairs, Operations, and Manufacturing Engineering-to address systemic and cross-functional issues.
  
• Provide technical guidance, coaching, and informal mentorship to R&D engineers and associates on CAPA processes, problem-solving methodologies, and regulatory expectations.
  
• Support CAPA owners in developing realistic timelines, following CAPA SOPs, and defining appropriate effectiveness verification plans and acceptance criteria.
  
• Support internal and external audits and inspections by providing CAPA documentation, investigation rationale, and technical explanations.
  
• Maintain clear traceability between CAPA investigations, corrective actions, effectiveness checks, and related design and risk documentation.
  
• Identify opportunities to improve CAPA execution quality and efficiency and contribute to broader quality system and R&D process improvements.
  
• Serve as a technical CAPA subject matter expert within the R&D organization.
  

Minimum Requirements

• 
  
• Bachelor's degree in Engineering or related technical discipline; advanced degree preferred.
  
• 5+ years of experience in R&D engineering within a medical device organization.
  
• Demonstrated experience managing and executing CAPA activities within product design and development.
  
• Strong understanding of regulatory requirements, including FDA regulations and ISO 13485.
  

Required Knowledge, Skills and Abilities

• 
  
• Expert-level knowledge of CAPA methodologies and root cause analysis tools (e.g., Fishbone, 5 Whys, FMEA) and risk management practices.
  
• Strong analytical and problemsolving skills with exceptional attention to detail.
  
• Ability to provide clear technical guidance and support to junior engineers without direct supervisory responsibility.
  
• Effective verbal and written communication skills for presenting findings across all organizational levels.
  
• Experience creating statistically sound sampling plans and acceptance criteria for effectiveness verification.
  
• Proficiency with CAPA and documentation systems; TrackWise experience preferred.
  
• Indepth knowledge of medical device regulations, design control processes, and quality system expectations.
  

Salary Range: $115k - $140k

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.

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.