Quality Assurance Administrator in Peterborough

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 Administrator to join our Quality & Regulatory team and help ensure our growing portfolio of devices continues to meet the highest global quality and regulatory standards.

• Assist in managing Design Control in regards to global Quality standards regulations and other requirements.
• Participate in the QA design reviews and release process ensuring that it maintains the requirement of ISO 13485:2016, regulatory requirements and our quality system.
• Review/preparation of quality documentation as required for product introduction and improvement, including material and sterilisation controls ISO 10993, ISO 11135.
• Documentation control to ensure implementation of changes to procedures within the QMS and technical files as standards evolve.
• Support in maintaining quality procedures across supply chain partners and manufacturers to ensure compliance to standards.
• Assist the team to ensure quality audit actions are completed in a timely manner.

• Degree or equivalent in physics, chemistry, engineering, materials science, or a closely related field.
• Experience of working with ISO-based quality systems in pharmaceuticals or, ideally, medical devices.
• Experience in QA/QC administration, with a major focus on design and change control under ISO 13485:2016.
• Knowledge or experience of design and development processes.
• Understanding of material and sterilisation compatibility processes, including ISO 10993 and ISO 11135.
• Previous experience working with eQMS systems (electronic Quality Management Systems) is preferred.
• Experience with validation activities.
• Be a self-starter, with strong motivation and the ability to take ownership of tasks.
• Demonstrate good written communication skills, especially in preparing technical or quality documentation.
• Have effective interpersonal and communication skills, able to liaise with colleagues across multiple departments and external partners.
• Work with a high level of attention to detail and accuracy.
• Show strong organisational and time management skills, able to handle conflicting priorities and meet tight deadlines.

• Directly contribute to improving cancer care for thousands of patients by ensuring our technologies are safe, effective and compliant.
• Work with innovative, market-leading medical devices in a growing, mission-driven company.
• Partner with experienced quality, regulatory, clinical, engineering and commercial professionals who will support your learning and development.
• Be part of a dynamic environment where your work underpins successful product launches and ongoing clinical impact.

If you’re passionate about quality, motivated by improving cancer care and excited to support innovative medical technologies, we’d love to hear from you.