Johnson & Johnson Careers
Primary Quality Field Action Engineer
Somerville, New Jersey
Requisition ID: 8573180801
Ethicon, a member of Johnson & Johnson's Family of Companies, is recruiting for a Primary Quality Field Action Engineer 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. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
You, the Primary Quality Field Action Engineer will:
- Execute activities related to the field action process to ensure compliance with internal and external requirements.
- Partner with Quality Operations, Compliance, Regulatory, Marketing, R&D, Medical Safety, CAPA, and Medical Affairs and reports direct to the Quality Manager.
- You will support the investigation of product risk assessments, review and create necessary documentation to support ongoing Field Actions (including corrections, removals, and market withdrawals), and own the domestic communication with FDA on Field Action related issues.
- Support process improvement activities related to the product risk escalation and field action processes. Provide periodic reports & presentations related to product risk escalations and field action processes. Provide metrics to support various scorecards/ dashboards to upper management as needed. Attend and support the Risk Management Board meetings. Support FDA/BSI/TUV/JJRC and other regulatory authority inspections/audits by providing information and interfacing with auditors as needed.
- A minimum of a bachelor’s degree with medical, technical or business focus or equivalent experience is required.
- A minimum of 2 years Quality experience or related experience is required.
- Experience in the medical device, pharmaceutical or other highly regulated industry preferred.
- Knowledge of ISO and/or cGMP regulations is preferred. Experience in a FDA regulated environment is an asset.
- An ASQ certification (CQE, CQM, CRE or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.
- Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred. Candidate must be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Operations, Medical Affairs, Compliance, Manufacturing, etc.
- Candidate must be comfortable working in a fast-paced environment and prioritizing multiple issues at a time.
Key Skills / Knowledge Requirements:
- Strong written and verbal communication skills – specifically with the ability to effectively communicate with individuals in a clear, concise & effective manner
- Attention to detail and critical thinking skills
- Strong decision-making skills – able to make sound business decisions with sometimes limited information
- Effectively manages work & time to produce desired outcomes (time management)
- Able to multi-task and adequately deal with sudden changes in priorities
- Self-starter – work with minimal supervision
- Interpersonal - positively interacts with all levels, personalities, cultures & disciplines of organization to produce required results
- Team player that is also a strong individual contributor
- Results oriented - Able to work well in a fast-paced environment
- Knowledge of applicable Quality, FDA (Food & Drug Administration), and ISO (International Organization for Standardization) preferred
- This position may require up to 10% domestic/ international travel and will be based in Somerville, NJ
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)