Quality Assurance Specialist

4 days ago

Singapore beBeequality Full time $3,200
Quality Assurance Specialist

Are you looking for a challenging and rewarding career in quality assurance? We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team.

About the Role

This is an excellent opportunity to work with a dynamic and innovative company that values quality and compliance. As a Quality Assurance Specialist, you will play a key role in ensuring the quality of our products and services, maintaining regulatory compliance, and contributing to the growth and success of our organization.

Key Responsibilities
  • Implement and maintain a Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR, EU MDR, and other applicable regulations.
  • Support document control, management reviews, audits (internal & external), CAPA, product complaints, and training.
  • Act as an independent reviewer for validation protocols (IQ/OQ/PQ) and reports.
  • Communicate regulatory or quality requirement changes to relevant departments and ensure timely implementation.
Regulatory Affairs
  • Assist with product registration, renewal, and change notifications across global markets.
  • Liaise with regulatory agencies, consultants, and authorized representatives to track and incorporate updated requirements into QMS.
  • Prepare and maintain dossiers and technical documents for regulatory submissions.
  • Maintain and update a listing of registered products and manage renewals.
  • Support post-market surveillance, recalls, and audit preparation with customers and regulatory bodies.
Requirements
  • Degree in Engineering (Mechanical) or Life Sciences (Pharmacy, Biology, Chemistry).
  • Diploma holders with 3+ years of relevant experience will be considered.
  • Knowledge of ISO 13485, cGMP, and international regulatory frameworks (HSA, FDA, TGA, NMPA, EU MDR).
  • Detail-oriented, proactive, and able to work independently.
Benefits

We offer a stable career with growth opportunities, exposure to international quality and regulatory frameworks, variable bonus, and employee benefits.

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