Johnson & Johnson Careers
Customer Quality Investigation Engineer III
Requisition ID: 4187190906
DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Customer Quality Investigation Engineer III to be located in West Chester, PA. DePuy Synthes, as part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.\
This Quality role offers exposure to a broad product portfolio. It also provides the opportunity to connect with many company functions. The primary responsibilities of this position include activities associated with conducting complaint investigations including: triage of incoming complaints, documenting requirements for evaluations and investigations, conduct of investigations and communications of performance and safety issues. You will initiate and lead projects involving failure investigations, root cause analysis using appropriate investigative techniques and statistical methods.
Additionally, this Engineer will summarize the results of data analysis and investigations into clear, concise complaint documentation and presentations and reports for peers, multi-functional teams and management. The Customer Quality Investigation Engineer supports business partner processes in post market surveillance, customer quality regulatory reporting, operations/operations quality and new product development. As needed you will be the key interface to ensure escalation of events in a timely manner and per procedure. You will compile data and prepare responses for the US and international regulatory agencies. Close collaboration is needed to provide daily support to the Complaint Teams and ensure complaint investigations are robust and well documented. You may lead training and mentor engineers, provide guidance and direction to peers, and serve as an expert in the investigation process. The Engineer participates on CAPA teams and acting as a CAPA Owner and Internal Audit Observation owner. You would prepare and present training materials for the complaint investigation process. Strong spreadsheet and presentation skills are need to prepare detailed analysis and present complaint information needed for management review and trending. This Engineer represents the complaint unit in Post Market Surveillance reviews.
This position may require up to 10% travel, including light international travel.
- A minimum of Bachelor’s Degree in Engineering is required with a preference for Biomedical or Mechanical Engineering.
- A minimum of 6 years of experience in a Good Manufacturing Practices (GMP) and/or ISO regulated environment.
- Previous root cause analysis skills.
- Ability to collaborate with business partners at all levels.
- Proficiency with Microsoft Office Suite.
- Excellent communication and presentation skills.
- Medical device industry.
- Experience conducting and reviewing complaint investigations.
- Project management experience.
- Knowledge of process and design excellence tools.
- Knowledge of CAD software.
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.
United States-Pennsylvania-West Chester-
Medical Device Business Services, Inc (6029)