Quality Assurance Manager (ISO 13485) Jobs in Chennai Medical Device Company
⚡ Hiring Now🏫 Chennai Medical Device Company Employment Zones
Chennai's private medical device companies distribute, service, and manufacture medical equipment, surgical instruments, and diagnostic devices from Guindy and Ambattur MIDC, employing Tamil-speaking biomedical engineers, medical sales executives, and service technicians.
Medical Device Company employment zones in Chennai include Guindy, Ambattur MIDC, Sholinganallur, Anna Nagar, Nungambakkam, T. Nagar, Adyar, Velachery, Taramani, and Perungudi.
📋 Job Description
Jobzi is sourcing qualified candidates for Quality Assurance Manager (ISO 13485) positions in Chennai's private Medical Device Company sector. This is a full-time opportunity with a reputed Medical Device and Equipment employer in Chennai offering competitive salary, structured growth, and a professional work environment. Tamil communication skills are preferred alongside English for professional and business interaction in Chennai.
📌 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 Chennai.
✅ 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
Frequently Asked Questions
What types of jobs are available in medical device companies in Chennai?
Private medical device companies in Chennai hire across manufacturing, quality, engineering, sales, and regulatory functions. Production operators and quality inspectors work on the shopfloor in cleanroom assembly. Field service engineers and application specialists support hospitals and diagnostic labs. Sales executives and product managers drive revenue through hospital and distributor channels. Regulatory affairs and quality assurance professionals manage CDSCO MDR 2017 compliance, ISO 13485 audits, and international device registrations.
What qualifications and certifications are needed for medical device jobs in Chennai?
Engineering roles require B.E./B.Tech. in Biomedical, Mechanical, or Electronics. Life science roles require M.Sc. or B.Sc. in relevant subjects. ISO 13485 QMS awareness is valued across quality and manufacturing roles. CDSCO MDR 2017 knowledge is essential for regulatory affairs. IEC 60601 electrical safety and CE marking exposure helps in quality engineering. GMP and Lean Manufacturing training strengthens production candidatures. Field service and clinical sales roles benefit from BLS certification and device demonstration skills.
What is the salary range and career growth in the medical device sector in Chennai?
Entry-level production and quality roles in Chennai medical device companies typically start between Rs.13,000 and Rs.32,000 per month. Mid-level field service engineers and application specialists earn Rs.22,000 to Rs.68,000. Sales managers, regulatory managers, and QA managers earn Rs.45,000 to Rs.1,15,000. Senior leadership such as business development managers and general managers can earn Rs.55,000 to Rs.2,80,000 or more. Career growth pathways lead from technical roles into product management, clinical sales, or regulatory leadership.
What does a Quality Assurance Manager do in a Chennai medical device company?
A Quality Assurance Manager in a Chennai medical device company owns the ISO 13485 quality management system, leads internal and external audits, manages the CAPA system, and oversees supplier qualification. They drive risk management per ISO 14971, conduct management reviews, and ensure process validations are executed per QMS requirements. They also prepare the organisation for CDSCO inspections and regulatory quality assessments. This is a senior cross-functional role requiring strong leadership, regulatory knowledge, and system thinking.
What certifications are required for QA Manager jobs in Chennai medical device companies?
A QA Manager in a Chennai medical device company should ideally hold B.E. or M.Sc. credentials combined with ISO 13485 Lead Auditor or Internal Auditor certification. Knowledge of ISO 14971 risk management, IEC 60601 for electrical devices, and CDSCO MDR 2017 QMS requirements is essential. Validation experience covering IQ, OQ, and PQ protocols is highly valued. Candidates with prior experience managing notified body audits and CDSCO facility inspections command premium compensation and faster hiring decisions.
What is the salary for a QA Manager with ISO 13485 experience in Chennai?
QA Managers with ISO 13485 leadership experience in Chennai medical device companies earn between Rs.50,000 and Rs.1,15,000 per month. Managers responsible for multi-site QMS implementation, CDSCO inspection readiness, and supplier qualification programmes earn at the top of this range. Companies holding or pursuing CE marking or USFDA registration additionally value cross-regulatory QMS knowledge and offer enhanced compensation. Performance bonuses linked to audit outcomes and zero major non-conformances are common motivators for senior quality leaders.
What is the salary for Quality Assurance Manager (ISO 13485) in Chennai Medical Device Company in
A Quality Assurance Manager (ISO 13485) in Chennai earns between Rs.52,500 and Rs.1,17,500 per month in July 2026, depending on experience, skills, and employer.
What experience is required for Quality Assurance Manager (ISO 13485) jobs in
5 - 12 Years of relevant experience is typically required for Quality Assurance Manager (ISO 13485) positions in Chennai's private Medical Device Company sector.
வேலை விவரம் - தமிழில்
Chennai-ல் Quality Assurance Manager (ISO 13485) வேலைவாய்ப்பு. மாத சம்பளம் ரூ.52,500 முதல் ரூ.1,17,500 வரை. 5 - 12 Years અனுபவம் தேவை. Medical Device Company-ல் Full Time பணி. ஆர்வமுள்ளவர்கள் Jobzi மூலம் விண்ணப்பிக்கலாம்.