Johnson & Johnson Careers
Senior Quality Engineer, New Product Introduction & Lifecycle Management
Somerville, New Jersey
Requisition ID: 0346180821
The Ethicon business is a member of Johnson & Johnson’s Family of Companies and is currently recruiting for a Senior Quality Engineer, New Product Introduction & Lifecycle Management to be located in Somerville, NJ.
The Ethicon business offers a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
Ethicon Biosurgery is a leading provider of proven solutions to address a range of bleeding and leaking situations – from routine to problematic -- during surgical procedures. Our product portfolio includes SURGICEL® proprietary oxidized regenerated cellulose hemostats; gelatin powder and sponges; a flowable hemostatic matrix; human thrombin, and EVICEL® fibrin sealant. Additionally, Ethicon Biosurgery encompasses also the Biopatch® dressing line to prevent catheter-related bloodstream infections (CRBSI).
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.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Somerville
Ethicon Inc. (6045)