Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Field Action Quality Engineer, to be based in either Cincinnati, OH or 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.
The purpose of the Field Action Quality Engineer III is to plan, coordinate, and execute all aspects of field actions (including corrections, removals, and market withdrawals) on behalf of the business to ensure compliancy to our regulations and ensure we continue to provide our customers with the very best product offerings possible. When the business decides to take field action, the Field Action Quality Engineer manages the field action process and leads the strategy, collaboration, and execution of associated activities throughout the world on behalf of Ethicon. Successful Field Action executions help keep Ethicon compliant to all associated regulations, but also maintains our strong company brand and ensures surgeons continue to trust our products so lives can continue to be saved and/or improved at the highest of levels.
- Execute activities related to the field action process (and the product risk assessment process when needed) to ensure compliance with internal and external requirements.
- Lead the data collection, analysis, and reporting of associated business metrics for the product risk escalations and field action processes to various scorecards, business partners, and company dashboards.
- Support FDA/BSI/TUV/MDSAP and other regulatory authority inspections/questions by providing information as well as help defend the Field Action process in both internal and external audit front rooms, when needed.
- Partner with Event Management, Marketing, Medical Affairs, Customer Service, Product Quality, Legal Manufacturer, Regulatory Affairs, Worldwide Field Services, Supply Chain, and various international affiliate partners to execute worldwide field actions.
- Participate or lead project-based improvement activities related to the product risk assessments and field action processes. Attend and support the Product Risk Assessment Board meetings, when possible.
- Support other Event Management processes (e.g., CAPA, Non-Conformance, etc.) when necessary.
- The following computer skills will be utilized in this role: Basic Windows applications (Excel, MS Word, etc.), efficient typing ability, Custom Applications (e.g. COGNOS, ADAPTIV, SIEBEL, AQR, etc.), Electronic document management, archive & retrieval systems.
- A minimum of a Bachelor's degree in Engineering, Life Science, Physical Science or a related field is required; an advanced degree is an asset.
Experience and Skills:
- A minimum of 4 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 an 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.
- Outstanding communication skills in both giving and receiving information (verbal, written, in person, phone)
- Demonstrated collaboration with multiple worldwide departments/sites
- Willingness to challenge the status quo in the spirit of continuous improvement
- Understanding of risk management and failure investigations
- Very well organized and can handle multiple ongoing projects simultaneously
- While part of a team, able to execute process without significant direction/oversight
- Leadership ability to guide and influence others through Field Action and Escalation processes
- Understanding of other quality system processes (CAPA, complaints, NC, etc.)
- Able to stay adaptable to a changing fast-paced environment
- Conflict management and influencing
- Results & Performance Driven; assumes personal ownership for business results and solutions; makes the customer central to all thinking
- Willingness to have flexible work hours to support International stakeholders and/or business deadlines
- This position will be located in either Cincinnati, OH or Somerville, NJ and may require occasional travel (less than 10%) domestically.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
North America-United States-New Jersey-Somerville
Ethicon Inc. (6045)