Product Quality Vigilance Lead

6 days ago


Manila, National Capital Region, Philippines Manpower Philippines Remote Work Freelance Full time
Job Description

At Manpower Philippines, we are seeking a highly skilled PQV Analyst to join our team. As a PQV Analyst, you will play a crucial role in handling E2E product quality complaint activities and adverse events.

You will be responsible for performing Medical Device Report (MDR) assessments, managing team processes to ensure completeness, consistency, and accuracy, and identifying opportunities for improvement.

The ideal candidate will have 1-5 years of experience in Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related highly regulated industries.

  • Knowledge of medical safety environment and regulation
  • Global mindset and demonstrated ability for change initiatives, project management, and developing strong relationships
  • Working knowledge of regulatory requirements: 21 CFR parts 4, 820, 803, 806, 210, 211, 314, ISO 13485:2003, ISO 14971:2007/2012, ICH Q10, GDP, GMP, GVP, MEDEV 2.12, CMDR, and the Medical Device Directive 93/42/EEC


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