Quality Assurance Lead
Our company is seeking a highly skilled Quality Assurance Lead to join our team. As a key member of our operations team, you will play a critical role in ensuring the quality and integrity of our products.
Key Responsibilities:
* Maintain and evolve our Quality Management System (QMS) to ensure compliance with relevant 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.
Requirements:
* 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.
* Degree in Engineering, Science, or a related technical field.
What's on Offer:
* A high-impact role within a dynamic and collaborative environment.
* Opportunity to shape and lead the quality function during a critical phase of growth.
* Competitive salary, benefits, and equity participation.