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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
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