Quality Assurance Administrator
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Job Location:
Monthly Salary:
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
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 worlds leading physicians and hospitals offer women with breast cancer more precise less invasive treatment and avoid surgery when it isnt 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 were just getting started.
Were 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:
In this position you can expect to be a key quality voice within cross-functional teams with responsibilities including:
- 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. Youll 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 marketleading magnetic technologies in a growing hightech medical device environment focused on advancing breast cancer care.
- Growth; Collaborate with worldclass quality clinical and engineering professionals in a culture that prioritises learning mentorship and your professional development.
- Purpose; Be part of a missiondriven organisation where your work provides the foundation for successful product launches and global clinical impact.
If youre passionate about medical device quality thrive in a fastpaced environment and want your work to make a real difference in cancer care wed love to hear from you.
Apply now to join Endomag a Hologic company as our next Quality Assurance Specialist and help shape the future of breast cancer treatment.
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Required Experience:
Unclear Seniority
Key Skills
About Company
Hologic is a global champion of women’s health. We integrate The Science of Sure into everything we do to help improve and save lives through early detection and proactive treatment.
