Quality Assurance Expert
We are seeking a Quality Assurance Expert to join our core team and take ownership of quality function.
About the Role
The Opportunity:
* Maintain and evolve the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR 820, and other applicable regulations.
* Oversee all quality aspects of internal manufacturing operations, including batch release, in-process controls, and product inspections.
* Provide quality oversight for subcontract manufacturing partners, including audits, quality agreements, and supplier performance management.
* Lead internal and external audits, manage CAPAs, and ensure continuous improvement across all quality processes.
About You:
* 5+ years experience in quality assurance within the medical device industry, ideally with Class II/III devices.
* Strong working knowledge of ISO 13485, FDA QSR, MDR, and relevant global regulatory frameworks.
* Experience with both internal and contract manufacturing environments.
* Demonstrated ability to build, maintain, and improve quality systems in a fast-paced setting.
* Practical, solution-oriented approach with excellent communication and collaboration skills.
What We Offer
A high-impact role within a well-backed innovation-driven start-up. Opportunity to shape and lead the quality function during a critical phase of growth. Competitive salary, benefits, and equity participation. A dynamic and collaborative environment where your contributions directly influence company success.