[Medical Device] QA Senior Manager
Spring Professional
Taiwan
9天前

Job Function

  • determing, negotitation and review on in-house QMS procedure, standard, and specificaiton.
  • assessing customer requirement and ensuing that those are met
  • cordinate and lead the quality planning establishment
  • vender management in term's of quality
  • vender audit
  • ensuring the manufacturing process comply with standard, product specifucaiton, and customer requirement
  • lead the process of CAPA, nonconfoorming control procedure, and customer complaint.
  • device and review specifications for products or process
  • supervise inspectors, technicians and other staff and provide guidance and feedback for quality staff.
  • oversee all product development procedures to identify deviations from quality standards
  • keep accurate documentation and perform statistical analysis
  • be on the lookout for opportunities for improvement and develop new efficient procedures
  • Requirement

  • Working knowledge of Six Sigma, quality tools like DOE, SPC.
  • Working knowledge of plastic injection tooling and molding.
  • Minimum of 10 years directly applicable work experience in regulated industry, preferably for medical device manufacturer.
  • Familiar with ISO 9001 a must. Prefer 21CFR820 and ISO 13485.
  • BA or BS degree in life science or engineering field.
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