Job Title

Our long-term client Endomag, now part of the Hologic group, has partnered with CAPU Search to recruit their next QA Manager.Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.This is a fantastic opportunity to join a company at the forefront of womens 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 complianceKey responsibilities and duties:Serve as a leader and mentor of the QA Compliance team. to ensure continuous growth and improvementAssure quality products and processes by enforcing quality standards and regulations and testing of materials and products by our virtual supply chain.Maintain the companys MDR ISO 13485/MDSAP quality system and CE certification.Represent the company during audits by its Notified Body or other organisationsLead the QMS integration activities with HologicOversee 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 organisationOversee 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 processesPrepare 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 surveillanceEnsure requirements for product traceability and ensure controls are in place where it relates to issues with product quality and post-market surveillanceOversee 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 organisationEnsure activities meet with and integrate with organisational requirements for health and safety, legal stipulations, environmental policies and general duty of care.Individual specificationQualificationsDegree or equivalent in a relevant scientific/engineering or closely related field.Qualifications relevant to QAExperience and Knowledge10-15 years experience in QA ISO quality systems, ideally, medical devices or pharmaceuticals.Experience and working knowledge of Product Lifecyle requirements in Medical Devices sectorExperience working with or implementing eQMS systemsLead Auditor experienceExperience of direct interaction with regulatory authorities would be desirableFull understanding of the ethos and 8 principles of ISO13485Understanding and working knowledge of ISO14971Quality and Process knowledge/experience around material and sterilisation compatibility processes. ISO10993, ISO11135, ISO11737Knowledge and understanding of Validation requirements and processesEvidence of experience working in a busy and demanding environment within a team and individuallyAbilities and SkillsSelf-starter with strong motivational skillsEvidence of management experienceExcellent written skills, demonstrated in a range of contextsEvidence of effective communication and inter-personal skillsInnovative strategic planning and excellent problem-solving skillsEvidence of ability to work with critical attention to detail and high levels of accuracyProven organisational and time management skills to effectively handle conflicting priorities and ensure tight deadlines are metGood IT skills (MS Office) are requiredExperience in working for a dynamic organisationOtherWillingness to occasionally travel in UK/US and ROW