Johnson & Johnson Careers
Customer Quality Investigation Engineer II
Requisition ID: 1678180917
DePuy Synthes Companies of Johnson & Johnson is seeking a Customer Quality Investigation Engineer II located in West Chester, PA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Customer Quality Investigation Engineer II primary responsibilities 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. Initiate and lead projects involving failure investigations, root cause analysis using appropriate investigative techniques and statistical methods.
Summarizing the results of data analysis and investigations into clean, concise complaint documentation and presentations and reports for peers, cross-functional teams and management. Support business partner processes in post market surveillance, customer quality regulatory reporting, operations/operations quality and new product development. Operates in a safe, effective, and professional manner compliant to all policies, procedures, and regulations including health and safety.
POSITION DUTIES & RESPONSIBILITIES:
- Triage incoming complaints
- Document requirements for investigations
- Investigate customer complaints for product quality issues
- Lead projects involving failure investigations. Root cause analysis
- Utilize statistical tools to analyze complaints and corrective actions
- Participate in HHEs as required
- Work with manufacturing, R&D, Medical Affairs, and international affiliates as required.
- Summarize results of various data analysis into clear and concise presentations and reports for peers, cross-functional teams and management
- Summarize data to support post market surveillance, regulatory responses, etc.
- Interface with key business partners including R&D, Operations, Post Market
- Risk Management and Surveillance, Quality, Regulatory and Compliance, to insure complete and thorough investigations.
- Conduct user interviews and manufacturing and R&D visits to ensure rapid response to field safety issues.
- As needed, be key interface to ensure events are escalated in a timely manner and per procedure.
- Gather data working and preparing response for the US and international regulatory agencies
- Provide daily support to the Complaint Teams and ensure complaint investigations are robust and well documented.
- Assist in training and mentoring of new employees, provide guidance and direction to peers, and serve as an expert in the investigation process.
- Participate on CAPA teams and acting as CAPA Action and Internal Audit task owner
- Other duties as assigned.
- A minimum of Bachelor’s Degree in Engineering is required.
- A minimum of 2 years’ experience in a GMP and/or ISO regulated environment is required.
- Medical device industry preferred
- Previous root cause analysis skills are required.
- Experience conducting and reviewing complaint investigations highly preferred.
- Project management experience preferred
- Ability to collaborate with business partners at all levels is required.
- Knowledge of process and design excellence tools preferred.
- Proficiency with Microsoft Office Suite required.
- Knowledge of CAD software highly preferred.
- Excellent communication and presentation skills required.
This position is based in West Chester, PA and may require up to 10% travel, including light international travel.
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
Depuy Orthopaedics. Inc. (6029)