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Customer Quality Investigation Engineer III
West Chester, Pennsylvania
Requisition ID: 7458171218
DePuy Synthes Companies of Johnson & Johnson is seeking a Customer Quality Investigation Engineer III to be 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.
Do you want to work on a role that includes activities associated with conducting complaint investigations including: triage of incoming complaints, documenting requirements for evaluations and investigations, conducting investigations and communications of performance and safety issues?
As a Customer Quality Investigation Engineer III, you will 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 clear, 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.
- Lead in training and mentoring of engineers, provide guidance and direction to peers, and serve as an expert in the investigation process. Act in Supervisor’s role as backup when required.
- Participate on CAPA teams and acting as CAPA Owner and Internal Audit Observation owner
- Approve Investigations
- Prepare training materials for complaint investigation process and present as needed to stakeholders and management
- Prepare, perform detailed analysis and present complaint information needed for management review and trending
- Represent complaint unit in Post Market Surveillance reviews. Complete action items as assigned from Management review, trending and PMS reviews.
- Other duties as assigned.
- A minimum of Bachelor’s Degree in Engineering is required.
- A minimum of 6 years of experience in a GMP and/or ISO regulated environment.
- Medical device industry experience is highly 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 may require up to 10% travel, including light international travel.
This role will be based in West Chester, PA and does not offer relocation benefits.
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.
United States-Pennsylvania-West Chester
Depuy Orthopaedics. Inc. (6029)