High-Level Quality Assurance Professional

1 week ago


Rawalpindi Cantonment, Pakistan beBee Careers Full time
Quality Assurance Manager

This role involves ensuring that products and services meet customer requirements and regulatory standards. The successful candidate will have extensive experience in quality assurance, particularly in the medical device industry.

A key aspect of this position is developing and implementing quality management systems to meet ISO 13485, FDA 21 CFR Part 820, EU MDR, and other applicable standards.

Key Responsibilities:
  • Develop and Maintain Quality Management System: Develop, administer, and maintain a comprehensive Quality Management System (QMS) that aligns with international regulatory requirements.
  • Plan and Lead Audits: Plan and lead internal and external audits, including those conducted by notified bodies, FDA, and customers.
  • Document Control and CAPA: Develop and manage document control procedures, conduct root cause analysis, and implement corrective actions for process-related concerns.
  • Supplier Management: Qualify, audit, and monitor suppliers/subcontractors to ensure compliance with quality requirements.
Required Skills and Qualifications:
  • Bachelor's or Master's degree in Biomedical Engineering, Quality Management, or related field.
  • 5–10 years of experience in Quality Assurance in the medical device industry.
  • Proven experience with ISO 13485, 21 CFR Part 820, and EU MDR.
  • Experience in audits and regulatory inspections.

Benefits: Competitive salary, excellent benefits package, and opportunities for professional growth and development.

How to Apply:

Submit your resume and cover letter to [HR Contact].



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