Manager/Quality Manager

Our long-term client Endomag, now part of the Hologic group, has partnered with CAPU Search to recruit their next QA Manager. This is a fantastic opportunity to join a company at the forefront of women’s health innovation, developing minimally invasive technologies that have already improved the lives of thousands of breast cancer patients worldwide. As Endomag continues its journey within Hologic, this role offers the chance to lead quality assurance through meaningful growth and transformation.

Endomag is certified to ISO 13485, MDSAP, EU MDR and has CE certification for Class IIa, IIb and III medical devices. The job holder will lead our QA compliance team and be responsible for ensuring quality compliance in line with medical device standards and regulations across the organisation. This role is a critical part of the Quality team and the company is seeking driven, creative, communicative team members with leadership capability to help continue to deliver on Endomag’s promise.

You will have responsibility for:

• The maintenance of the certificates together with the development of documentation to support certification of new products and growth of the quality system.
• Serving as a leader and mentor of the QA Compliance team.
• Assuring quality products and processes by enforcing quality standards and regulations and testing of materials and products by our virtual supply chain.
• Maintaining the company’s MDR ISO 13485/MDSAP quality system and CE certification.
• Overseeing and managing document control in regard to global Quality standards regulations and other requirements.
• Ensuring compliance for the internal quality system and providing suitable interpretation to directors, managers and staff within the organisation and all other relevant regulatory requirements within the quality system.
• Preparing quality documentation as required for other worldwide territories e.g. FDA, TGA etc. to support submission.
• Managing customer tracking as it relates to quality of products and post-market surveillance.
• Ensuring requirements for product traceability and ensuring controls are in place where it relates to issues with product quality and post-market surveillance.
• Overseeing and helping PRRC conduct vigilance activities.
• Working with the Supplier Quality function to maintain quality procedures across supply chain partners and manufacturers to ensure compliance to standards.
• Maintaining awareness and knowledge of Quality and EU/US Regulatory standards and ensuring compliance for the internal quality system and providing interpretation to the organisation.
• Ensuring activities meet with and integrate with organisational requirements for health and safety, legal stipulations, environmental policies and general duty of care.

Qualifications:

• Degree or equivalent in a relevant scientific/engineering or closely related field.
• Qualifications relevant to QA.
• 10-15 years’ experience in QA ISO quality systems, ideally, medical devices or pharmaceuticals.
• Experience and working knowledge of Product Lifecycle requirements in the Medical Devices sector.
• Experience of direct interaction with regulatory authorities would be desirable.
• Quality and Process knowledge/experience around material and sterilisation compatibility processes.
• Evidence of management experience.
• Innovative strategic planning and excellent problem-solving skills.
• Proven organisational and time management skills to effectively handle conflicting priorities and ensure tight deadlines are met.
• Good IT skills (MS Office) are required.
• Willingness to occasionally travel in UK/US and ROW.