Medical Device Quality Engineer II
We are looking for Medical Device Quality Engineer II for our client in West Chester, PA
Job Title: Medical Device Quality Engineer II
Job Location: West Chester, PA
Job Type: Contract – 12 Months / Contract to Hire / Direct Hire
“US citizens and those authorized to work in the US are encouraged to apply. We are unable to sponsor H1b candidates at this time.”
- 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.
- DePuy Synthes job descriptions may be revised at management's discretion, at any time.
- 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.
PROFESSIONAL EXPERIENCE REQUIREMENTS:
- A minimum of 4years experience in a GMP and/or ISO regulated environment.
- Medical device industry preferred
- Previous root cause analysis skills is required.
- Experience conducting and reviewing complaint investigations highly preferred.
- Project management experiencepreferred
- 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.
- A minimum of Bachelor’s Degree in Engineering is required.