Quality Assurance Lead in Oxford

This range is provided by Cure Talent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

Direct message the job poster from Cure Talent

MedTech QARA Recruitment – Simply Complicated

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 510(k) 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 ISO 13485
• Demonstrable experience preparing for and leading audits
• Proven experience migrating to an eQMS
• Proven experience supporting FDA readiness activities including QSub or other 510(k) 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.

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Quality Assurance

Industries

Medical Equipment Manufacturing