Medical Device Quality Engineer II

Confidential Company  •  West Chester, PA

5 - 7 years experience  •  IT Consulting/Services

Salary depends on experience
Posted on 08/12/17 by Cynet EngineeringTeam
West Chester, PA
5 - 7 years experience
IT Consulting/Services
Salary depends on experience
Posted on 08/12/17 by Cynet EngineeringTeam

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.”

Job Description:

OVERALL RESPONSIBILITIES: 

  • 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. 

EDUCATIONAL REQUIREMENTS: 

  • A minimum of Bachelor’s Degree in Engineering is required.
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