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.
About the role:
Endomag is certified to ISO 13485, MDSAP, EU MDR and has CE certification for a 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 to continue to deliver on Endomags’ 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. You will be responsible for the product release function to ensure continued compliance of our existing portfolio. Which include class IIa, IIb and Class III sterile devices. As such, this role will involve interacting with all other functional teams and especially Product Engineering and R&D. to support the introduction of new products (including sterile), ensuring design improvements to the existing portfolio are documented correctly to the required standards to maintain compliance
Key responsibilities and duties:
- Serve as a leader and mentor of the QA Compliance team. to ensure continuous growth and improvement
- Assure quality products and processes by enforcing quality standards and regulations and testing of materials and products by our virtual supply chain.
- Maintain the company’s MDR ISO 13485/MDSAP quality system and CE certification.
- Represent the company during audits by its Notified Body or other organisations
- Lead the QMS integration activities with Hologic
- Oversee and manage document control in regard to global Quality standards regulations and other requirements. ensure compliance for the internal quality system and provide suitable interpretation to directors, managers and staff within the organisation
- Oversee the change control process ensuring that it maintains the requirement of ISO 13485; and all other relevant regulatory requirements within the quality system.
- Oversee the CAPA and internal/external audit processes
- Prepare quality documentation as required for other worldwide territories eg FDA, TGA etc to support submission.
- Manage customer tracking as it relates to quality of products and post-market surveillance
- Ensure requirements for product traceability and ensure controls are in place where it relates to issues with product quality and post-market surveillance
- Oversee and help PRRC conduct vigilance activities.
- Work with the Supplier Quality function to maintain quality procedures across supply chain partners and manufacturers to ensure compliance to standards.
- Maintain awareness and knowledge of Quality and EU/US Regulatory standards and ensure compliance for the internal quality system and provide interpretation to the organisation
- Ensure activities meet with and integrate with organisational requirements for health and safety, legal stipulations, environmental policies and general duty of care.
Individual specification
Qualifications
- Degree or equivalent in a relevant scientific/engineering or closely related field.
- Qualifications relevant to QA
Experience and Knowledge
- 10-15 years’ experience in QA ISO quality systems, ideally, medical devices or pharmaceuticals.
- Experience and working knowledge of Product Lifecyle requirements in Medical Devices sector
- Experience working with or implementing eQMS systems
- Lead Auditor experience
- Experience of direct interaction with regulatory authorities would be desirable
- Full understanding of the ethos and 8 principles of ISO13485
- Understanding and working knowledge of ISO14971
- Quality and Process knowledge/experience around material and sterilisation compatibility processes. ISO10993, ISO11135, ISO11737
- Knowledge and understanding of Validation requirements and processes
- Evidence of experience working in a busy and demanding environment within a team and individually
Abilities and Skills
- Self-starter with strong motivational skills
- Evidence of management experience
- Excellent written skills, demonstrated in a range of contexts
- Evidence of effective communication and inter-personal skills
- Innovative strategic planning and excellent problem-solving skills
- Evidence of ability to work with critical attention to detail and high levels of accuracy
- Proven organisational and time management skills to effectively handle conflicting priorities and ensure tight deadlines are met
- Good IT skills (MS Office) are required
- Experience in working for a dynamic organisation
Other
Willingness to occasionally travel in UK/US and ROW
