Job Title: Quality Assurance Expert
About the Role:
We are seeking a skilled Quality Assurance expert to lead our quality function during a critical phase of growth. As a key member of our team, you will be responsible for maintaining and evolving our Quality Management System (QMS) in compliance with relevant regulatory frameworks.
Key Responsibilities:
* Maintain and improve the QMS to ensure robust, scalable quality systems are in place to support internal manufacturing and external supply chain operations.
* 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.
* Support internal R&D, engineering, and operations teams with quality input during project development and tech transfer.
* Act as the quality lead for product lifecycle activities from development through commercialization.
Requirements:
To be successful in this role, you will need:
* 5+ years of 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.
* Degree in Engineering, Science, or a related technical field.
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 and benefits package.
* Equity participation.
* A dynamic and collaborative environment where your contributions directly influence company success.