Medical Device Quality Assurance Specialist

2 days ago


Noida, Uttar Pradesh, India beBeeQuality Full time ₹ 8,00,000 - ₹ 12,00,000

Quality Assurance Expert


Job Overview
We are seeking a skilled Quality Assurance Expert to join our team. The ideal candidate will have experience in reviewing and preparing quality documents, as well as conducting audits and investigations.

Responsibilities
1. Review and prepare quality documents, including URS, GxP Risk Assessment, and Qualification protocols (OQ, PQ).
2. Conduct audits and investigations to identify areas for improvement.
3. Handle post-implementation changes and execute OQ and PQ procedures.
4. Prepare compliance reports for internal and external audits and implement corrective actions.
5. Initiate, investigate, and evaluate change control, CAPA, and deviation processes.
6. Prepare and review SOPs and ensure their implementation and effectiveness.
7. Investigate and report market complaints and product failures at the shop floor level.
8. Review GMP documents online.
Functional Area
Quality Assurance Expert, Quality Assurance jobs, Regulatory affairs, Quality control, Risk management, Auditor, Medical Device Manufacturing Recruitment Agencies

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