Job description
Quality Manager — Medical Devices & Diagnostic Laboratory Startup
Salary: £55,000-£60,000 + EMI option scheme
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. This position offers the chance to build quality functions from the ground up with scope to become the long-term quality leader of the company.
Responsibilities
* Own and improve the existing QMS.
* Work with quality and regulatory consultants to build and implement ISO 15189 processes.
* Support ISO 13485 certification readiness.
* Establish internal audit processes and prepare the company for external audits, certification, and future UKAS accreditation.
* Support development of SOPs, document control, CAPA, change control, deviation/nonconformance handling, supplier qualification, and training records.
* Work closely with technical staff to ensure quality by design principles whilst ensuring compliance is practical.
Essential Requirements
* 5+ years in a Quality role in medical devices, diagnostics, clinical labs or another regulated life science environment
* Life science degree
* Demonstratable understanding of ISO 15189
* Practical, risk‑based approach to quality.
* Excellent written communication.
* Strong interpersonal skills and ability to work directly with the CEO and technical team to build and improve systems from the ground up.
* Willingness to work in a fast‑moving startup environment and an ability to be dynamic and prioritise work accordingly.
Desirable
* Good understanding of ISO 13485
* Experience in a startup, scale‑up, or small regulated company.
* Familiarity with molecular workflows, PCR, sample handling, contamination control, or clinical testing environments.
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