Quality Assurance Administrator

Salary not available. View on company website.

Hologic, Hilton, Cambridgeshire

Posted 3 days ago, 21 May | Get your application in today.

Closing date: Closing date not specified

Job ref: d27cb266736b4a9e8016f7ad35ba3528

Location ref: Hilton, Cambridgeshire

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, 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.

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.

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.

https://www.jobs24.co.uk/job/quality-assurance-administrator-126870247