Quality Assurance Lead

4 days ago

Oxford Oxfordshire, United Kingdom Cure Talent Full time

Cure Talent are delighted to be partnered with a rapidly scaling MedTech company developing an advanced contactless monitoring platform used in global clinical research. Their technology combines specialised sensing hardware, embedded software, cloud infrastructure and machine learning analytics to capture high accuracy nocturnal physiological data, and is now being deployed internationally as they expand their commercial footprint and prepare for key regulatory milestones including FDA clearance. Following significant commercial traction and an ambitious regulatory roadmap including FDA engagement and the implementation of an eQMS, they are seeking a QA Lead to take full ownership of the Quality Management System and drive the organisation's readiness for upcoming regulatory milestones. As the QA Lead, you will be the primary quality representative across the business. You will strengthen and mature the QMS, conduct a full gap analysis, lead the transition to an eQMS, ensure continual audit readiness and work cross functionally with engineering, product, clinical and commercial teams. You will also play a central role in preparing the organisation for FDA submissions, ensuring internal systems, documentation and design controls meet the expectations for 510k clearance. To be successful as the new QA Lead you will need Proven QA and or QARA experience in a small, fast scaling MedTech organisation Proven experience owning and improving a GCP and GAMP5 aligned QMS, supporting transition towards ISO13485 Demonstrable experience preparing for and leading audits Proven experience migrating to an eQMS Proven experience supporting FDA readiness activities including QSub or other 510k aligned preparation If you are seeking a role where you can directly shape the quality framework of a high growth MedTech business and support critical FDA-facing milestones, we would love to hear from you.

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