About the JobPosition: QMS OfficerLocation: Ernakulam, KeralaWork Mode: On-SiteWe are looking for a proactive and detail-oriented QMS Officer to support our Quality Management System (QMS) activities and ensure compliance with international and national medical device regulations. This on-site role in Kochi, Kerala, involves working closely with the cross-functional teams including hardware, software, and regulatory affairs.Key Responsibilities✅ QMS – Maintaining and updating QMS documentation in line with ISO 13485 and FDA 21 CFR Part 820.✅ Compliance Support – Ensure regulatory compliance with CDSCO (India), EU MDR, and other applicable standards.✅ Documentation Control – Maintain controlled documents, records, and logs for audits and inspections.✅ Internal Audits – Support internal audits, prepare checklists, and document findings.✅ CAPA Follow-Up – Assist in tracking non-conformances, CAPAs, and improvement actions.✅ Training Support – Coordinate quality training sessions and help with training records.✅ Supplier Coordination – Assist in gathering supplier quality documentation and monitoring partner compliance.Qualifications
Job Title
QMS Officer