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Quality Assurance Specialist

2 weeks ago

Manila, National Capital Region, Philippines Somnomed Philippines Inc. Full time
About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at Somnomed Philippines Inc. In this role, you will play a key part in ensuring the quality and regulatory compliance of our products.

Key Responsibilities
  • Manage controlled documents and maintain records, including upkeep of documents and records master list.
  • Maintain site master file and prepare quality-related trainings for all employees.
  • Support lead and coordinator during certification audits, regulatory inspections, and other external audits.
  • Participate in internal audits and quality walkthroughs, helping prepare audit plans, programs, checklists, organizing meetings, and raising related NCs.
Requirements
  • Bachelor's Degree in Life Sciences or Scientific Engineering required.
  • 3-5 years collective experience in manufacturing quality control and assurance, preferably in medical device or pharmaceutical industry.
  • Broad understanding of ISO 9001 required; ISO 13485 desirable.
  • Knowledge of US FDA 21 CFR 820 Quality Systems Regulation, EU Medical Device Regulation, and other regional quality regulations preferred.