Senior Manager - Quality Assurance

Role & responsibilities

• Ready for unannounced audits at any time from notified bodies, MOH,USFDA.
• Serve as an MR for the site
• Ensure that all the cross-functional team are prepared and ready for the ongoing audits with all the relevant updated documents.
• Creating risk mgt and design documentation as per SOP.
• Control of all department SOPs, formats and records, preparation, approval and issuance
• Planning and conducting IQA and follow-ups for NCCs making summaries for the final report
• Planning and conducting calibration and validation of all equipment and instruments by external agencies and keeping the updated report.
• Investigating and responding to the customers complaint for export complaints in coordination with QC and production.
• Planning and conducting QMS meetings regularly and addressing the issues.
• Responding to the customers queries, with respect complaints, quality, manufacturing process, COAs
• Follow-up, collecting and preparing quality objective reports on monthly basis.
• Perform the responsibility of Person Responsible for Regulatory Compliance (PRRC).
• Planning, collecting documents and preparing MRM reports.
• Closing NCR report by verifying the action.
• Raising CAPAs for the non-conformance and closing by providing appropriate justification for internal and external observations.
• Product release authorization.

Preferred candidate profile

Post Graduation in science/pharmacy OR Engineering graduation

12-15 years of experience in QA function for a medical device

MUST have experience in mfg facilities for medical devices who are certified for EUMDR and 510 K approved products.