Quality Control Lead - Diagnostics
Hartmann Young is partnered with an innovative diagnostics company based out of Cambridge, whose mission is to deliver high-quality, reliable products that make a real difference to patient care and safety. With collaboration, compliance, and continuous improvement at their core, the team is seeking a Quality Control Lead to join the business.
The Role
* Supervise QC teams and oversee testing across raw materials, in-process checks, and final product release.
* Partner with R&D, Manufacturing, Operations, QA, and Regulatory to integrate QC into every stage of the product lifecycle.
* Lead method validation, supplier quality oversight, stability studies, and non-conformance investigations.
* Use data-driven insights (SPC, KPIs, trending) to ensure quality, compliance, and continuous improvement.
* Foster a strong quality culture across two sites, supporting product reliability and patient safety.
The Requirements
* Demonstrable QC experience in a regulated manufacturing environment (ISO 13485 / IVD / medical devices).
* Proven track record in validating QC methods and stability testing.
* Experience with devices incorporating plastics, electronics, reagents, and other complex components.
* Strong supervisory experience, with the ability to develop and inspire QC teams.
* Excellent planning, problem-solving, and communication skills.
* A degree in life sciences, chemistry, engineering, or related discipline – or 10+ years as a QC manager in a similar IVD/medical device environment.
If this sounds like you, reach out on or apply directly below. We'd love to hear from you