Senior Medical Device Quality Professional

3 days ago


Singapore beBeeQuality Full time $45,000 - $60,000

Job Summary:

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  • Lead the implementation and maintenance of Product Inspection Process and Product Release Process, including Imported Finished Goods, and Returned Products

Key Responsibilities:

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  • Maintain compliance of country specific labeling process
  • Implement and track Quality Hold(Global & local) in 3PL
  • Drive improvement for 3PL Quality Management System, implement and maintain Quality Agreements
  • Execute rework activities and initiate internal complaints resulting from labeling and other regulatory non-compliance
  • Perform first article inspection (FAI) for product distributed in Asia Pacific & greater China region

Requirements:

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  • Bachelor's degree in a related field and 3 years of previous experience in quality and/or manufacturing environment in the medical device industry
  • Good knowledge of medical or pharmaceutical regulations as relating to documentation and understanding of medical devices regulations (e.g. ISO13485)

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