Medical Devices Quality Manager Location: Cambridge Department : Global Quality Systems Job type : Fixed term Join us and make a difference when it matters most At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees. Role and Responsibilities Lead the design, implementation, and maintenance of an effective global Quality Management System supporting Medical Devices ensuring: Systems are in place to ensure changes are adequately documented, assessed, implemented and verified, by setting Change Control Governance procedures, including through measuring and reporting; Systems are in place to identify and manage risks through application of Quality Risk Management principles, maintaining Site Risk Register and ensure effective linkages are in place in relation to QRM between key QMS elements such as Change Control, Validation, Non-conformances/Deviations; Regulatory Intelligence processes are established to maintain visibility and awareness of changes in legislation, guidelines and standards and to implement such changes as required; Systems are in place to facilitate the identification and tracking of Corrective and/or Preventive Actions and sets Governance processes to ensure CAPAs are executed in a timely fashion, commensurate with their criticality and complexity, and evaluated in relation to its effectiveness. Fulfil the responsibility of the Management Representative as defined in ISO 13485, ensuring: Appropriate documentation is in place to demonstrate compliance to the requirements of the standard; Communication to senior management on the performance, effectiveness, and the need for improvement of the global QMS supporting Medical Devices, including during regular QMS meetings e.g. Management Review Communication and awareness to Mundipharma of the regulatory and QMS requirements applicable to Medical Devices; Appropriate delegation is in place for the day-to-day operation of the QMS supporting medical devices. Lead the implementation of Medical Devices Regulation 2017/745 as overall Program Manager and ensure, in collaboration with other functions, a Quality and Regulatory compliance program is in place to ensure: Functional gap analysis is completed, actions identified and resources allocated for timely completion of all actions; Actions identified are tracked and status of implementation visible and routinely communicated to stakeholder and delays or issues are promptly escalated to the appropriate governance boards; MDR compliance gaps, including technical files, are addressed across all products and that all applicable QMS requirements are in place via the Global and/or Local QMS and compliance is transparent and documented. Appropriate metrics are in place and effectively communicated to ensure proactive identification of areas for improvement and action as required; global inspection readiness program for Medical Devices is in place and support is provided to entities hosting external inspections and audits. What you’ll bring Certification in Quality Systems Management and/or auditing or similar Certification in ISO 13485 Quality Systems Management for Medical Devices and/or auditing; Extensive practical experience (8 years) in Quality Management Systems within the Pharmaceutical Industry and/or Medical Devices Extensive practical experience (10 years) in Quality Management Systems within Medical Devices. Extensive knowledge and experience in designing and managing Quality Management Systems according to ISO 13485 (preferred) or ISO 9001 or ICH Q10; Good knowledge of Medical Device Regulation 2017/745; and technical file requirements Internal auditing certification and experience in GxP auditing; Solid experience in hosting external audits by customers and competent authorities; Demonstrated competency in the application of Quality Risk Management principles; Excellent communication skills (including public presentation and technical report writing skills) and ability to communicate and interact at all levels of the business and externally; Ability to operate in a matrix environment and to engage and motivate other stakeholders to achieve common goals through effective collaboration. What we offer in return ● Flexible benefits package ● Opportunities for learning & development through our varied programme ● Collaborative, inclusive work environment Diversity and inclusion Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do. We are on a journey and will seek to move forward together through education and awareness to build a culture that welcomes and celebrates diversity and uniqueness. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect. About Mundipharma Mundipharma is a global healthcare company focussing on customers across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease as well as other severe and debilitating disease areas. Their guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit www.mundipharma.com. Join our talent pool If you’re not sure this role is right for you but you’re keen to hear about future opportunities at Mundipharma, join our talent community and be the first to hear about new roles. Additional Job Description: Primary Location: GB Cambridge Job Posting Date: 2025-02-28 Job Type: Fixed Term Contract (Fixed Term)