Quality Assurance Administrator

Quality Assurance Administrator focuses on assisting in managing design control in regards to global quality standards regulations and other requirements.

What the role involves

• Assisting 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.
• Documentation control to ensure implementation of changes to procedures within the QMS and technical files as standards evolve.
• Supporting in Maintaining quality procedures across supply chain partners and manufacturers to ensure compliance to standards.
• Assisting the team to ensure quality audit actions are completed in a timely manner.
• Show strong organisational and time management skills, able to handle conflicting priorities and meet tight deadlines.

Skills and requirements

• Review/preparation of quality documentation as required for product introduction and improvement, including material and sterilisation controls ISO 10993, ISO11135.
• 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.

Candidate fit

• Have effective interpersonal and communication skills, able to liaise with colleagues across multiple departments and external partners.

Additional role context

• Endomag, a Hologic company is a global technology company on a mission: we believe everyone deserves a better standard of cancer care.
• 2016, regulatory requirements and our quality system.
• Understanding of material and sterilisation compatibility processes, including ISO 10993 and ISO 11135.