Job Summary
The QMS Engineer establishes, maintains, and audits the Quality Management System (QMS) for Class II medical devices. This role is responsible for authoring and managing technical documentation, CAPA systems, change control, and design controls to ensure compliance with ISO 13485:2016, EU MDR 2017/745 (CE Mark), and FDA 21 CFR Part 820 / QMSR.
Key Responsibilities
- ISO 13485 QMS Maintenance: Author, update, and manage Quality Manuals, SOPs, and Work Instructions (WIs). Conduct internal audits and manage ISO 13485 surveillance/certification audit readiness.
- CE Mark Technical Files (EU MDR): Draft and update Technical Documentation / Technical Files for Class II devices per EU MDR 2017/745 Annex II & III, including Post-Market Surveillance (PMS) plans and Post-Market Clinical Follow-up (PMCF) inputs.
- US FDA Compliance (21 CFR Part 820 / QMSR): Author and maintain Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR). Support 510(k) quality documentation and FDA inspection readiness.
- Risk Management (ISO 14971): Maintain Risk Management Files (RMF), DFMEA/PFMEA, and hazard analysis across product lifecycles.
- CAPA & Non-Conformance: Lead Non-Conformance Reports (NCR) and Corrective & Preventive Action (CAPA) investigations using 5-Why and Fishbone root-cause analysis.
- Change Control & Validation: Oversee Engineering Change Orders (ECO), document control, and IQ/OQ/PQ process validation protocols/reports.
Key Requirements
- Education & Experience: Bachelor’s in Biomedical, Mechanical, or Quality Engineering with 3–5 years of QMS and technical writing experience in Class II medical devices.
- Core Standards: Hands-on experience with ISO 13485, EU MDR 2017/745, FDA 21 CFR 820 / QMSR, and ISO 14971.
- Certifications (Preferred): ISO 13485 Lead/Internal Auditor, ASQ CQE/CQA.
Pay: ₹325,616.22 - ₹600,000.00 per year
Work Location: In person
