Quality Assurance Manager (ISO 13485) Jobs in Coimbatore Medical Device Company

📋 Job Description

Jobzi is sourcing qualified candidates for Quality Assurance Manager (ISO 13485) positions in Coimbatore's private Medical Device Company sector. This is a full-time opportunity with a reputed Medical Device and Equipment employer in Coimbatore offering competitive salary, structured growth, and a professional work environment. Tamil communication skills are preferred alongside English for professional and business interaction in Coimbatore.

📌 Key Responsibilities

• Implement and maintain the ISO 13485 quality management system across the organisation
• Lead internal QMS audits and coordinate external certification and surveillance audits by Notified Bodies
• Manage the CAPA system including root cause analysis, corrective action implementation, and effectiveness checks
• Own risk management activities per ISO 14971 including FMEA reviews and risk file maintenance
• Qualify suppliers through on-site audits, approved vendor list management, and periodic re-qualification
• Prepare and lead management review meetings with documented minutes and action tracking
• Ensure production validation activities IQ, OQ, and PQ are planned and executed per QMS requirements

🎓 Qualifications and Requirements

• Have you led ISO 13485 certification or re-certification audits as the QMS owner?
• How do you manage the CAPA system and measure CAPA effectiveness?
• Are you familiar with ISO 14971 risk management and FMEA for medical devices?
• Have you qualified suppliers through audits and approved vendor list processes?
• Have you managed a CDSCO inspection or regulatory quality audit?
• How do you structure management review meetings under ISO 13485?
• What is your experience with process and equipment validation IQ, OQ, and PQ?
• Good Tamil and English communication skills for team coordination and client interaction in Coimbatore.

✅ Required Skills

🏆 Certifications and Qualifications

B.E./B.Tech. (Biomedical, Mechanical, or Electronics) for engineering and field service roles; M.Sc. or B.Sc. in Life Sciences for IVD application and quality roles; ISO 13485 quality management system training; CDSCO MDR 2017 regulatory compliance knowledge for regulatory affairs roles; IEC 60601 and CE marking awareness for quality roles; Lean Manufacturing and GMP training for production roles; BLS and medical device demonstration certification for clinical sales specialists