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QA Manager
About the role
Lead, maintain, and continuously improve the Quality Management System (QMS) in accordance with ISO 13485 and medical device regulations. Ensure compliance across the full product lifecycle, including development, manufacturing, release, and post-market. Oversee risk management, including risk files, benefit-risk analysis, and lifecycle updates. Plan and support internal and external audits (notified body, supplier, regulatory). Act as key contact for audit readiness, responses, and corrective actions. Manage CAPA, non-conformances, deviations, and change control. Support supplier quality management and qualification. Ensure documentation control, version management, and data integrity.
Requirements
- Several years of QA experience in the medical device industry, ideally at a smaller company
- Strong hands-on knowledge of ISO 13485 and ISO 14971
- Proven experience leading/supporting audits and inspections
- Solid understanding of quality systems, risk management, and product development
- Experience in cross-functional, international environments
- Fluent English, spoken and written