Senior QA Manager
Spring Professional
Taiwan
28天前

Responsibilities :

  • Reporting to QA Director, you will lead and manage the QA and Customer Service teams, providing on-time solutions to resolve customer complains;
  • Defining Customer Service Process and correcting misleading behaviors

  • Familiar with ISO 13485, QSR system, good at handling RMA
  • Control Quality issues and activities during product production
  • Ability to participate in quality audits, as needed
  • Support programs in combination biologic / device platforms. Provide compliance oversight to Medical Device regulations and QSRs
  • Independently provide quality leadership and oversight activities to project teams and day-to-day cGMP manufacturing and testing for clinical trial material
  • Redefining proper policies or SOPs to improve production Quality and product Quality
  • Utilize risk management and failure analysis proactively to anticipate events and implement mitigation.
  • Audit suppliers, ensuring production outputs are met with correct inputs
  • Candidate Profile :

  • 8+ years’ QA experience in Medical Device Manufacturing business with at least 3 years in managerial level.
  • Master or above degree in Biotech, Engineering, Chemistry, or other related fields.
  • Must be fluent in English with good cross-functional communication skills.
  • QA related certificate is a plus
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