Head - Quality Systems

4 days ago

Malappuram, India Native Full time

Head - Quality Systems (Medical Devices)Designation: GM / Sr. GM / AVP - Quality SystemsLocation: HyderabadJob SummaryA well-established medical devices manufacturer is looking for a senior Quality Systems professional to lead its organisation-wide QMS function. The role involves strengthening compliance frameworks, improving documentation systems, managing audits, driving supplier quality governance, and ensuring the organisation maintains full alignment with international medical device standards including ISO 13485, MDR, MDSAP, and FDA 21 CFR Part 820.Key Responsibilities- Oversee the organisation’s QMS and ensure it consistently meets global regulatory requirements.- Direct internal audits and coordinate external assessments conducted by regulators, notified bodies, and customers.- Strengthen the CAPA program with systematic RCA, preventive actions, and structured closure of observations.- Maintain documentation integrity, record-keeping systems, version control, and regulatory traceability.- Evaluate and develop suppliers through audits, SCAR/CAPA follow-up, and performance tracking.- Partner with R&D, Manufacturing, Clinical, Regulatory and other teams to close gaps and enhance system robustness.- Facilitate training on QMS procedures, compliance expectations, and investigative methodologies.- Review quality metrics and initiate continuous improvement projects across the organisation.Qualifications- 18-25 years of experience in Quality Systems leadership in medical devices or regulated healthcare manufacturing.- Deep expertise in CAPA/RCA, complaint handling, post-market surveillance, supplier quality, and audit management.- Understanding of ISO 13485, MDR, MDSAP, FDA QSR, and documentation control systems.- Lead Auditor certifications preferred.- Strong collaboration, leadership maturity, and analytical decision-making capabilities

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