Quality Manager — Medical Devices & Diagnostic Lab Startup

Quality Manager — Medical Devices & Diagnostic Laboratory Startup

Contract type: Permanent, on‑site

Xgenera is a diagnostic company developing a multi‑cancer early detection test and preparing to establish a UK diagnostic service laboratory. We are looking for a hands‑on Quality Manager to own and develop our quality systems as we move from R&D and clinical trial execution toward commercial diagnostic testing.

This is a foundational role as an individual contributor. You will maintain and improve our ISO 13485‑aligned QMS while building the systems required for an ISO 15189 medical laboratory. You will work directly with the CEO and technical team to create pragmatic, audit‑ready processes that support speed, quality, and future accreditation.

You will be expected to write documents, create and improve processes, run quality activities, train the team, prepare for audits, and help make quality part of how the company works every day...