QA Manager/Engineer

We are seeking an experienced, detail-oriented, and hands-on QA Engineer/Manager to support the development, regulatory compliance, and lifecycle management of Class III medical device catheters. The ideal candidate will have a strong understanding of ISO 13485, EU MDR, international regulatory requirements, and associated guidance documents. This role requires cross-functional collaboration to ensure compliance in product development, verification and validation requirements, risk management, and post-market activities, while also supporting e.g. biocompatibility, usability, and product safety initiatives.

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