Quality Assurance Specialist
Endomag, a Hologic company – Cambridge-based, hybrid
Endomag, a Hologic company, is a global technology company on a mission: we believe everyone deserves a better standard of cancer care. Our magnetic technologies help many of the world’s leading physicians and hospitals offer women with breast cancer more precise, less invasive treatment – and avoid surgery when it isn’t needed.
Using our Sentimag® probe, clinicians can accurately stage breast cancer with our Magtrace® lymphatic tracer and localise tissue with our Magseed® marker. Tens of thousands of women have already benefited from our solutions – and we’re just getting started.
We’re now looking for a Quality Assurance Specialist to join our growing team and play a key role in bringing innovative medical devices to market and maintaining the quality of our existing portfolio.
What To Expect
- Drive Design Controls; Act as the quality lead for the design and development lifecycle, ensuring all design activities meet global regulatory requirements and internal QMS standards.
- Risk Management Leadership; Lead and facilitate risk management activities in accordance with ISO 14971, including FMEAs and hazard analyses, to ensure product safety and performance.
- Technical File Ownership; Oversee the creation, review and maintenance of Design History Files (DHF) and associated technical documentation to support global regulatory submissions.
- V&V Oversight; Review and approve Verification and Validation (V&V) protocols and reports, ensuring design inputs are fulfilled and user needs are adequately validated.
- Compliance Expertise; Provide specialist guidance on material biocompatibility (ISO 10993) and sterilisation controls/validation (e.g. ISO 11135, ISO 11737) for both new product introductions and changes to existing products.
- Cross-Functional Collaboration; Work closely with R&D, Supply Chain, Manufacturing and external partners to ensure seamless design transfer and consistent quality across our partner network.
- Continuous Improvement; Lead and contribute to design reviews, manage quality- and design-related audit actions, and ensure timely resolution. You’ll help keep our processes aligned with evolving standards and best practices.
What We Expect
- Degree or equivalent in Engineering, Physics, Materials Science, Microbiology, Molecular Biology or a closely related technical field.
- Experience in design and change control under ISO 13485:2016 requirements is a major consideration.
- Proven experience in a Design Assurance or Quality Engineering role in the medical device industry (ISO 13485:2016 environment).
- Hands-on experience with:
- Design and change control under ISO 13485:2016.
- Design and development processes for medical devices, ideally sterile devices or pharmaceuticals.
- Risk assessments and risk management to ISO 14971:2019.
- Material and sterilisation compatibility processes, including ISO 10993, ISO 11135, ISO 11737.
- Validation activities (process, equipment, test methods).
- Experience working with eQMS (electronic Quality Management Systems) is preferred; familiarity with PLM tools is advantageous.
- Good IT skills, particularly MS Office (Word, Excel, PowerPoint).
- Self-starter with strong motivational skills who takes ownership and drives tasks to completion.
- Good written communication skills, with the ability to produce clear, structured documentation and technical justification.
Why Join Endomag, a Hologic Company?
- Impact; Directly contribute to improving cancer care for thousands of patients by ensuring that our technologies are safe, effective and compliant.
- Innovation; Work with market‑leading magnetic technologies in a growing, high‑tech medical device environment focused on advancing breast cancer care.
- Growth; Collaborate with world‑class quality, clinical and engineering professionals in a culture that prioritises learning, mentorship and your professional development.
- Purpose; Be part of a mission‑driven organisation where your work provides the foundation for successful product launches and global clinical impact.
If you’re passionate about medical device quality, thrive in a fast‑paced environment and want your work to make a real difference in cancer care, we’d love to hear from you.
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