Ethicon Endo- Surgery, Inc. a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Field Action Engineer located in Cincinnati, OH.
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 along with innovative energy devices for surgery.
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 Senior 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.
- This position will support the investigation of product risk assessments, review and create necessary documentation to support ongoing worldwide 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.
- 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 is required, preferably in a medical, technical or related field of focus.
- An advanced degree is preferred.
- A minimum of four (4) years of Quality or related experience is required.
- Experience in a medical device, pharmaceutical or FDA regulated industry is preferred.
- Prior knowledge of ISO and/or cGMP regulations is preferred.
- An ASQ certification (CQE, CQM, CRE or CQA), Six Sigma (Green Belt, Black Belt) or Process Excellence certification is preferred.
- Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred.
- Ability to communicate effectively with all levels within Quality as well as cross functionally is required.
- Prior knowledge of quality system processes (CAPA, complaints, non-conformity) is preferred.
- Strong organizational skills, time management skills and ability to self-manage in a complex/ time sensitive environment is required.
- Prior experience effectively working through periods of change, ambiguity and complexity is required
- Experience thriving in a collaborate work environment is required.
- This position is located in Cincinnati, OH and may require up to 5% travel.
Ethicon Inc. (6045)