Medical Device - QMS Engineer

Tata Elxsi is among the worlds leading providers of design and technology services across industries, including automotive, broadcast, communications, healthcare, and transportation. Tata Elxsi works with leading OEMs and suppliers in the automotive and transportation industries for R&D, design, and product engineering services from architecture to launch and beyond.

Roles and Responsibilities:

• Implement, maintain, and improve the Medical Device Quality Management System in compliance with ISO 13485, FDA 21 CFR 820, MDSAP, EU MDR and applicable regulatory requirements.
• Ensure implementation and maintenance of software life-cycle processes as per IEC 62304.
• Responsible for design and development of medical devices in compliance with ISO 13485, ISO 14971, and IEC 62304, ensuring effective design controls and regulatory compliance.
• Prepare, review, and control QMS documentation including SOPs, procedures, records, and formats.
• Manage Document Control, Change Control, and Training records.

• Plan and conduct Internal Audits and support external audits (Notified Body, FDA).
• Handle CAPA, Non-Conformance, deviations, and root cause analysis.
• Support Risk Management activities as per ISO 14971.
• Coordinate Management Review Meetings and prepare reports.
• Ensure compliance in Design Controls, Production, and Quality Control activities.
• Monitor Supplier Quality, conduct supplier evaluations, and audits.
• Support Regulatory Affairs in submissions, renewals, and compliance activities.
• Handle Customer Complaints and support Post-Market Surveillance activities.
• Ensure calibration and validation activities are performed and documented.

Education & Skills preferred:

• Bachelors degree in Engineering / Pharmacy / Life Sciences or any equivalent.
• 3 to 8 years experience in Medical Device QMS.
• Strong knowledge of ISO 13485, ISO 14971, FDA QMSR, EU MDR IEC 62304.
• Experience in audits, documentation, and CAPA management.
• Good communication and documentation skills.
• Internal/ Lead Auditor certification (ISO 13485) will be beneficial.
• Exposure to Design Control documentation.