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Quality Engineer

Irvine, California
Responsibilities for the Quality Engineer
  • Responsible for the complaint handling process. Coordinate complaint-related activities across multiple functions and sites. Provide complaint handling and quality engineering expertise and consultation to significant / complex projects. 
  • Lead Review Committee meetings for confirmed product failures. Contribute to product safety, product quality, and customer satisfaction related decisions (both data-based and risk-assessment-based decisions). Ensure prompt escalation and complete documentation of product safety.
  • Ensure documentation and records are complete and in compliance with regulatory requirements. Participate and support internal, external audits and inspections. Ensure Post Market Surveillance activities are completed. 
  • Minimum BA/BS degree in science or other technical field. Experience in the medical device industry. Experience participating in internal and external inspections (e.g., FDA, LRQA). 
  • Knowledge on CAPA, complaint investigation, and field action processes. 
  • Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and give oral presentations 
  • Certified Quality Engineer desirable
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