Sorry, this particular job is closed. But feel free to fill out a General ApplicationSearch Jobs
Senior Quality Engineer, New Product Introduction & Lifecycle Management
You, the Senior Quality Engineer will:
- Function as the quality lead on New product development project teams as well as lifecycle management of current products, processes and associated materials in matters relating to Quality Engineering.
- Lead the development of comprehensive risk documentation for the products and processes including risk management reports and plans.
- Lead the development of comprehensive quality strategies
- Provide support and guidance to teams in design control, process validation and identification of product and process CTQs.
- Review and approve design verification/validation, method validation and process validation protocols and reports.
- Perform statistical data analysis, develop sampling plans, and create DOEs to support project
- Ensure test methods used to verify product design or manufacture of products/components are appropriate and are properly validated.
- Provide Quality engineering support to external material suppliers and/or finished goods manufacturers.
- Lead and/or support thorough investigations of customer complaints and quality issues (CAPAs, non-conformances, audit observations & etc.) while ensuring effective corrective and/or preventive actions.
- A minimum of a Bachelor’s degree in Engineering, Statistics, Chemistry, or Science related field is required.
- A minimum of 4+ years of related work experience in a highly regulated industry is required.
- Medical Device, Biopharmaceutical, Pharmaceutical or other highly regulated industry (BLA, PMA, 510K or equivalent) experience is required.
- Experience with New Product Development Processes is highly preferred.
- Intermediate to advanced knowledge in Statistics, Sampling Planning, Risk Assessment, Test method and Process Validation is required.
- Working knowledge of Medical Device design controls and product risk management is strongly preferred.
- Demonstrated ability to manage/lead Quality deliverables within projects having more than one task is required.
- Demonstrated ability to problem solve and collaborate effectively in matrix project team setting is required.
- Ability to provide guidance and direction to teams to ensure compliance to regulatory (e.g., cGMP, QSR, EU Directives, ISO standards, etc.) and company procedures is required.
- Experience collaborating and communicating quality requirements to external suppliers is strongly preferred.
- Ability to effectively prepare and/or evaluate technical documentation is required.
- Experience with Six Sigma/Process Excellence training, tools and/or certification is preferred.
- An ASQ Certification (CQE, CQA, CPGP, CMQ/OE) is a plus.
- Experience with providing hands on quality engineering manufacturing support which include inspection, testing, and sampling plan development is a plus.
- Experience with Combination Products, Biologics and Aseptic processing is a plus.
- This position is based in Somerville, NJ and may require up to 10% travel.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
United States-New Jersey-Somerville
- Industrial - Plant Electrical Mechanic in Millville NJ
- Director, Quality Assurance in Millville NJ
- CNC Programmer-Machinist in Alpharetta GA
- Safety Manager in Everett MA
- HR Manager in Suwanee GA
- Customer Service-Sales in Memphis TN
- Quality technician in Norcross GA
- Mechanical Assembler in Westford MA
- Packaging Supervisor in Olive Branch MS
- Client Services Advisor-Receptionist in Alpharetta GA
- Accounts Payable Coordinator in Milford MA
- Laboratory Assistant in Tucker GA
- Temp General Laborer in Rochester NH
- Coating Technician in Franklin MA
- Micro Solder Repair Technician in Norcross GA
- Quality Inspector in Lawrenceville GA
- Production Test Technician in Willmington MA
- EM Assembler in Willmington MA
- Assembly Technician in Flowery Branch GA
- Wiring Technician (Control Panels) in Buford GA
- Maintenance Mechanic - 3rd shift in Lincoln RI
- Laboratory Assistant in Marlborough MA
- Structural Engineer in Alpharetta GA
- Mechanical Designer in Alpharetta GA
- Material Handler in Memphis TN
- Mold Maker in Rochester NH
- Tool Die Maker in Rochester NH
- Machine Operator 2nd Shift in Salem NH
- Laboratory Automation Engineer in Marlborough MA
- Press Brake Operator in Lawrenceville GA
- Shipping-Stockroom in Lawrenceville GA
- Stockroom Helper in Lawrenceville GA
- Shop Helper (Machine) in Lawrenceville GA
- Customer Service Rep in Concord CA
- CNC Machinist in Flowery Branch GA
- Stainless Steel Finisher in Flowery Branch GA
- 3rd shift Packer-Picker-Puller in Newfield NJ
- 1st shift Picker Packer in Newfield NJ
- Painter in Lawrenceville GA
- Sanitation Lead in Attleboro MA
- CNC Machinist in Attleboro MA
- Maintenance Tech in Attleboro MA
- Warehouse-Manufacturing Associate in Natick MA
- Engineering Documentation Admin in Bedford NH
- Extrusion Manager in Mableton GA
- 2nd Shift Maintenance Supervisor in Newnan GA
- Laser Machine Operator in Flowery Branch GA
- AutoCAD Drafter in Conyers GA
- EM Assembler II in Westboro MA
- Material handler in Concord CA
- Manufacturing Design Engineer in Attleboro MA
- Manufacturing Engineer in Attleboro MA
- Precision Inspector- Fremont in Fremont CA
- Tax Administrative Assistant in Louisville KY
- Electronic Technician in Minneapolis MN
- Staff Accountant in Attleboro MA
- EM Assembler III Clean Room in Westborough MA
- Sr Systems Safety Engineer in Waltham MA
- TIG Welder-Aluminum in Flowery Branch GA
- Solderer in Stillwater MN
- Manufacturing Quality Engineer in Marlborough MA
- Industrial Motor Assembly Technician in Suwanee GA
- Account Executive in Cherry Hill NJ
- Surface Mount Machine Technician in New Hope MN
- Sr. Tooling Engineer in Woburn MA
- Lead Maintenance Mechanic in Conyers GA
- Robotics Engineer in Suwanee GA
- Assembler in Suwanee GA
- Precision Inspector in Concord CA
- Quality Technician II in Concord CA
- Facilities Maintenance Technician II in Concord CA
- Material Handler in Westborough MA
- Assembly Technician I 2nd shift in West Boylston MA
- Assembly Technician I in West Boylston MA
- Test Tech III in Westborough MA
- Quality Inspector 3rd Shift in Rochester NH
- Electronic Assembly Support in Alpharetta GA
- Electrical Technician in Lawrenceville GA
- Mechanical Technician in Lawrenceville GA
- Assembler in Lawrenceville GA
- Quality Control Technician in Billerica MA
- Extrusion Operator in Taunton MA
- Master Mechanic in Taunton MA
- Maintenance Electrician in Taunton MA
- Senior FPGA Design Engineer in Waltham MA
- Sales Support Admin in Chaska MN
- Scale Technician in August GA
- Electronic Assembler in Alpharetta GA
- Test Tech-Operator - weekend - 5 openings in Nashua NH
- Assemblers - Weekend Shift - in Nashua NH
- Test Tech-Operator - 2nd Shift - 8 openings in Nashua NH
- Assembler - 2nd Shift - in Nashua NH
- Test Tech-Operator - 1st Shift - 4 openings in Nashua NH
- Assemblers - 1st Shift in Nashua NH
- Machinist in Bedford NH
- Production Worker in Memphis TN
- Soldering Technician in Suwanee GA
- Material Coordinator in Westborough MA
- Utility Clerk in Lenox MA
- Machine Operator - 3rd Shift in Newton MA