Lead/Senior QA Engineer – Quality Management System (QMS)

About the role

The Lead/Senior QA Engineer (QMS) will own and continuously improve the company’s Quality Management System, ensuring compliance with ISO 13485, EU MDR, MDSAP and FDA 21 CFR Part 820. The role works across cross‑functional teams to maintain document control, drive CAPA activities and support audit readiness.

Key responsibilities

• Maintain and enhance the QMS to meet all applicable regulatory standards.
• Oversee document and record control, ensuring the Quality Manual, SOPs, work instructions and templates are current and accessible.
• Plan, coordinate and support internal, external, supplier and regulatory audits; act as lead auditor and ensure timely closure of findings.
• Lead non‑conformance investigations and CAPA processes using structured problem‑solving methods, monitoring effectiveness of actions.
• Support supplier qualification, manage supplier non‑conformances, and provide quality input for new product introductions.
• Drive change management activities, including design and process change control, training planning and documentation of medical device files and batch records.
• Own risk management files in accordance with ISO 14971 and keep risk assessments up to date.

Required profile

• Professional experience in medical device quality assurance, preferably at a senior or lead level.
• Demonstrated knowledge of ISO 13485, EU MDR, MDSAP and FDA 21 CFR Part 820 requirements.
• Hands‑on experience conducting internal and external audits and managing audit readiness.
• Proven ability to lead CAPA investigations and drive continuous improvement.
• Experience working with suppliers on quality issues and supporting NPI projects.
• Strong understanding of change control, document management and risk management (ISO 14971).

Required skills

• ISO 13485
• EU MDR
• MDSAP
• 21 CFR Part 820 (FDA QMS)
• ISO 14971 (Risk Management)
• Document control systems / electronic QMS platforms
• Audit management
• CAPA methodology