Owen Mumford are looking to hire a Group Quality Systems Manager Could this be your next role? Scope: We are seeking a highly motivated and experienced Group Quality Systems Manager to join our team. This critical role will ensure the overall compliance of Owen Mumfords global Quality Management System (QMS) and provide leadership across a range of quality and regulatory functions. You will be responsible for the day-to-day activities of our eQMS system, drive continuous improvement projects, and work closely with all levels of the business to assure the adoption of compliant ways of working. Key Responsibilities: QMS Compliance: Ensure the global QMS is fully compliant, covering areas such as exceptions, CAPA, deviations, training, validation, complaints, post-market surveillance, document control, and change management. Deputy for Group Quality & RA Director: Act as deputy for the Group Quality & RA Director, providing leadership on QMS-related matters and representing the company in customer visits. eQMS Management: Manage the eQMS system, including day-to-day operations, continuous improvement initiatives, and alignment to best practices. QMS Improvement: Drive improvement activities across individual QMS elements, ensuring that quality systems are continually refined and optimized. Project Management: Oversee QMS-related projects such as electronic system introductions and the implementation of risk-based approaches for validation. Strategy Development: Define and implement strategies to ensure quality and regulatory compliance during the industrialization of medical devices and medicinal products. Audit Representation: Host and co-host customer and regulatory audits, ensuring all processes and records are presented confidently and accurately. Qualification/Validation: Manage the review and approval of qualification/validation protocols and reports for tools, equipment, test methods, facilities, and computerized systems. Change Control: Provide key input to the Change Control process, ensuring effective management of change across the business. Team Leadership: Lead and develop a team, providing guidance, training plans, and performance management. Conduct annual appraisals, schedule activities, and foster a culture of continuous improvement. Collaboration and Communication: Build strong relationships across the business, ensuring effective communication and the smooth adoption of compliant practices. Support the Group Quality & RA Director with initiatives and escalate issues as necessary. Customer Interaction: Interface with customers to understand their requirements and present Owen Mumford's processes and quality records in a confident and assertive manner. Continuous Improvement: Drive initiatives to deliver measurable performance improvements, supporting the overall success of the quality management systems. To be successful in this role, you will need: Minimum of 5 years experience in the Medical Device or Pharmaceutical industry, with at least 1 year of experience with Validation documentation (or equivalent). Experience with software validation and the implementation of a data integrity program (preferred). Solid understanding of current regulatory requirements for device validation and familiarity with best practices. Proven success in delivering quality inputs for medical device and medicinal product industrialization projects. Strong knowledge of quality systems management, QMS activities, and Current Good Manufacturing Practices (cGMP). ISO13485 Auditor certification (preferred). Excellent verbal and written communication skills. Strong problem-solving, analytical, and decision-making skills, with the ability to manage complex issues under pressure. Ability to work independently, prioritize tasks, and manage time effectively. Ability to build and maintain strong relationships with customers and departments. High attention to detail and a commitment to Good Documentation Practices. What will we give you? You will be joining a successful, privately owned industry leader who are constantly innovating and looking to improve lives, empower patients and relieve the pressure on healthcare professionals. We invest heavily in our staff and offer a competitive salary and benefits package along with the opportunity to develop within the business. Additional benefits include: Remote working up to 2 days per week Flexi time covering 37.5 hours per week with core working hours of 9:30am-12 Noon and 2:00pm-4:00pm (3:30pm on Fridays) 25 days annual leave (with the opportunity to earn loyalty days with length of service) Company pension scheme with employer contributions Holiday purchase scheme (up to 10 days purchased per holiday year) Enhanced Family Friendly Policies Enhanced Sickness Pay Group Life Insurance BUPA Private Medical Care Cycle2Work Scheme Electric Car Scheme Wellbeing initiatives and support Annual company bonus Free parking, free tea & coffee and free fruit ? About us: Owen Mumford is a global leader in medical device design and manufacture. For over 70 years we have been inventing life-enhancing devices that are tested and proven to deliver an industry benchmark in the safety, accuracy and comfort of medication administration. This strong heritage is the springboard for our future as we help to shape the progress of the healthcare industry by bringing pioneering concepts and solutions to life in an accountable and sustainable way. Headquartered in the UK, Owen Mumford is a family-run business with a large global presence across North America, EMEA and APAC. Owen Mumford is an equal opportunities employer. We aim to ensure that no candidate or employee receives less favourable treatment on the grounds of gender, race, disability, sexual orientation, religion or belief, age, gender identity, marital or civil partnership status, pregnancy or maternity. Every job offer is subject to satisfactory references and compliance with vetting requirements applicable to the job role.