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QA Manager
About the role
Inossia improves fracture treatment for osteoporotic patients through vertebral augmentation solutions adapted to bone mechanics. They are entering a pivotal growth phase with their first product launch and transition to commercial operations. The QA Manager will lead, maintain, and continuously improve the Quality Management System (QMS) per ISO 13485 and medical device regulations, ensure compliance across the full product lifecycle, oversee risk management, plan and support audits, manage CAPA and non-conformances, support supplier quality management, and ensure documentation control 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
