At a Glance
- Tasks: Ensure quality in innovative medical devices and collaborate with cross-functional teams.
- Company: Endomag, a Hologic company, dedicated to improving cancer care.
- Benefits: Impactful work, professional growth, and a supportive learning culture.
- Other info: Join a mission-driven team focused on innovation and excellence.
- Why this job: Make a real difference in breast cancer treatment and patient care.
- Qualifications: Degree in a technical field and experience in quality assurance for medical devices.
The predicted salary is between 35000 - 45000 € per year.
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. Apply now to join Endomag, a Hologic company, as our next Quality Assurance Specialist and help shape the future of breast cancer treatment.
Quality Assurance Administrator in Cambridge employer: Hologic
Endomag, a Hologic company, is an exceptional employer located in Cambridge, offering a hybrid work environment that fosters innovation and collaboration. With a strong commitment to improving cancer care, employees are empowered to make a meaningful impact while benefiting from a culture of continuous learning and professional growth. Join a mission-driven team where your contributions directly enhance the quality and safety of life-saving medical technologies.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance Administrator in Cambridge
✨Tip Number 1
Network like a pro! Reach out to people in the medical device industry, especially those working in quality assurance. Attend relevant events or webinars and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO standards and quality management systems. Be ready to discuss how your experience aligns with the role at Endomag. We want to see your passion for improving cancer care shine through!
✨Tip Number 3
Showcase your hands-on experience! Bring examples of past projects where you’ve led risk management activities or worked on design controls. This will help us see how you can contribute to our mission of enhancing breast cancer treatment.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining our team at Endomag and making a difference in cancer care.
We think you need these skills to ace Quality Assurance Administrator in Cambridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Assurance Administrator role. Highlight relevant experience in design control and risk management, and don’t forget to mention any ISO 13485:2016 knowledge you have!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about improving cancer care and how your skills align with our mission at Endomag. Keep it concise but impactful!
Showcase Your Technical Skills:We love seeing hands-on experience! Be sure to include specific examples of your work with validation activities, eQMS, and any relevant technical documentation you've created. This will help us see your expertise in action.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Hologic
✨Know Your Standards
Familiarise yourself with ISO 13485:2016 and ISO 14971:2019 standards. Be ready to discuss how your experience aligns with these regulations, especially in design control and risk management. This shows you understand the industry's requirements and can contribute effectively.
✨Showcase Your Technical Skills
Prepare to talk about your hands-on experience with validation activities and material compatibility processes. Bring examples of past projects where you successfully managed design history files or conducted risk assessments. Concrete examples will make your skills stand out.
✨Emphasise Collaboration
Since this role involves cross-functional teamwork, be prepared to share experiences where you collaborated with R&D, manufacturing, or supply chain teams. Highlight how you contributed to seamless design transfers and maintained quality across different departments.
✨Communicate Clearly
Practice articulating your thoughts clearly and concisely. You’ll need to produce structured documentation, so demonstrate your written communication skills during the interview. Consider preparing a brief presentation on a relevant topic to showcase your ability to convey complex information simply.
