Quality Assurance Administrator
Cambridgeshire, England, United Kingdom Full-time Posted 2 days ago
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.
What To Expect
Salary: £32,000 – £40,000 gross per year
The final offer will depend on experience, skills, and alignment with internal pay structures. In addition, we offer a comprehensive benefits package including pension and insurances.
#L!-RH1
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.
What To Expect
- Assist in managing Design Control in regards to global Quality standards regulations and other requirements
- Participate 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, ISO11135
- 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.
Salary: £32,000 – £40,000 gross per year
The final offer will depend on experience, skills, and alignment with internal pay structures. In addition, we offer a comprehensive benefits package including pension and insurances.
#L!-RH1