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.
📌 QMS Engineer (Medical Device) (Ahmedabad)
🏢 NSV
📍 Ahmedabad