At a Glance
- Tasks: Ensure quality in innovative medical devices and lead design control processes.
- Company: Join Endomag, a Hologic company, dedicated to improving cancer care.
- Benefits: Competitive salary, hybrid work model, and opportunities for professional growth.
- Other info: Collaborative environment focused on mentorship and continuous improvement.
- Why this job: Make a real impact on cancer care while working with cutting-edge technology.
- Qualifications: Degree in a technical field and experience in quality assurance for medical devices.
The predicted salary is between 40000 - 50000 € 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.
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.
Quality Assurance Specialist 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 have the opportunity to make a meaningful impact while working alongside world-class professionals in a culture that prioritises growth and mentorship. Join us to be part of a mission-driven organisation where your contributions directly enhance the quality and safety of medical devices, ensuring better outcomes for patients worldwide.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance Specialist in Cambridge
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device industry on LinkedIn or at local meetups. We can’t stress enough how valuable personal connections can be in landing that Quality Assurance Specialist role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO standards and risk management processes. We recommend practising common interview questions related to quality assurance in medical devices, so you can showcase your expertise confidently.
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can leave a lasting impression. We suggest mentioning something specific from your conversation to show your genuine interest in the role.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about joining our mission to improve cancer care.
We think you need these skills to ace Quality Assurance Specialist in Cambridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that match the Quality Assurance Specialist role. Highlight your experience with ISO standards and any relevant projects you've worked on in the medical device industry.
Craft a Compelling Cover Letter:Use your cover letter to tell us why you're passionate about improving cancer care. Share specific examples of how your background aligns with our mission and the responsibilities of the role.
Showcase Your Communication Skills:Since good written communication is key for this role, ensure your application is clear and well-structured. Use bullet points where necessary and avoid jargon unless it's relevant to the position.
Apply Through Our Website:We encourage you to apply directly through our website. This way, your application will be processed more efficiently, and you'll have access to all the latest updates about the role and our company.
How to prepare for a job interview at Hologic
✨Know Your Standards
Familiarise yourself with ISO 13485:2016 and ISO 14971:2019 before the interview. Being able to discuss how these standards apply to quality assurance in medical devices will show that you understand the regulatory landscape and can contribute effectively.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully managed design controls or risk assessments. Highlighting your hands-on experience with V&V protocols or technical documentation will demonstrate your capability and readiness for the role.
✨Emphasise Collaboration Skills
Since the role involves cross-functional collaboration, be ready to discuss how you've worked with R&D, manufacturing, or supply chain teams in the past. Share examples of how you’ve facilitated communication and ensured quality across different departments.
✨Ask Insightful Questions
Prepare thoughtful questions about Endomag's current projects or challenges in quality assurance. This shows your genuine interest in the company and helps you assess if their mission aligns with your values and career goals.
