Company Description Inspiration Healthcare is a British based, global provider of medical technology, and our mission is to pioneer medical technology that improves outcomes of patients, starting with the very first breaths of life. We provide high-quality, innovative products to patients around the world that help to improve patient outcomes, and we actively invest in innovative product opportunities, disruptive technologies and, of course, our people. The Group currently consists of three companies: Inspiration Healthcare Ltd, SLE Ltd and Viomedex Ltd and, under these brands, we sell neonatal intensive care and operating theatre equipment around the world through a network of distributors into over 75 countries. We also offer a full range of ambulatory infusion care devices for both hospital and homecare applications to customers across the UK and Ireland. Products range from highly sophisticated capital equipment through to single-use disposables all of which can help improve outcomes of extremely sick patients. We can proudly admit that we haven't come this far without entrepreneurial spirit, a solution driven attitude, and a determination to improve outcomes for premature and sick babies. So if making a positive difference to other people's lives resonates with you and you believe that you have what it takes to flourish and succeed in this role, then we'd love to hear from you. Position Job Purpose (Role Definition): The Supplier Quality Assurance Team Lead will manage and provide leadership to the Supplier Quality Assurance Team; is responsible for developing, implementing, maintaining and supporting the Manufacturing and Supplier Quality Manager on the promotion of the Quality Assurance strategy; is responsible for supporting the Manufacturing and Supplier Quality Manager with the quality compliance culture within the Group ensuring that all staff are aware of the Companies' Business Management System and the need to adhere to it. The position also includes maintaining the Companies Quality Management System and ensuring compliance to all applicable regulations and standards; has responsibility for ensuring compliance with ISO 13485, Medical Device Single Audit Program (MDSAP), and other regulations under which the Companies sell their products; has responsibility for keeping abreast of changes to ISO 13485 and MDSAP regulations impacting on the business. This position is also responsible in keeping the Manufacturing and Supplier Quality Manager and other key stakeholders up to date with such regulatory changes; supports the Manufacturing and Supplier Quality Manager with Continued Improvement activities and initiatives across the Companies using best practices such as Lean Six Sigma and Lean Manufacturing. Main Duties and Responsibilities Ensure that supplier quality processes needed for the Business Management System within the Group are documented in accordance with Medical Device Single Audit Program (MDSAP), Medical Device Directive (MDD) and Medical Device Regulation (MDR); Report to Manufacturing and Supplier Quality Manager on the effectiveness of the supplier quality processes within the Business Management System and any needs for improvement; Support the promotion of supplier quality awareness of applicable quality requirements and Business Management System requirements throughout the Group; Is responsible to reporting to the Manufacturing and Supplier Quality Manager on the supplier quality performance of the Quality Management System. Is responsible for the planning and preparation of supplier audits. Ensure compliance to all applicable supplier quality standards, regulations and internal procedures by proactively interpreting Quality requirements, and devising and implementing solutions to support the maintenance and enhancement of the Quality Management System and quality documentation throughout the Group; Manage with input from other business functions, supplier selection, approval and ongoing Supplier evaluation process. Support internal projects by providing guidance on supplier evaluation and other supplier related activities. Is responsible for the Management of supplier concessions and Supplier Corrective Action Report (SCARs); Periodic review of supplier certification and documentation; Manage, with input from other key stakeholders and work streams, the Supplier Quality performance Score Card analysis; Provide input to Supplier Quality performance for Management Review and other Top Management reviews; Participate in the CAPA process; Support the Manufacturing and Supplier Quality Manager with the preparation of the Group Quality Management Reviews; Travel to all Manufacturing Group sites is required in order to maintain visibility and support the Manufacturing and Supplier Quality Manager with the visibility and compliance of Quality Assurance needed for the Group; Travel to suppliers to perform supplier audits. Management Responsibilities Supplier Quality Assurance team. Requirements Experience and Qualifications Required Mandatory Previous experience in a Quality Assurance role in a Medical Device organisation, specifically Class II devices; Direct interaction with Regulatory authorities; Expert knowledge in ISO 13485 and MDASP requirements; Expert knowledge in Continuous improvement activities and problem solving techniques. Desirable ISO 13485 Lead Auditor; Previous experience in a Supplier Quality/Quality Management or Supplier Quality/Quality Lead role. Key Skills and Competencies A demonstrable and broad understanding of medical device quality assurance; The ability to interpret quality requirements to ensure that implications for users and processes are clear; The ability to learn quickly and establish a high degree of quality knowledge and expertise in different markets; The ability to engage and deliver compelling presentations to a varied audience, and communicate and present a technical subject matter in an understandable, coherent manner; The ability to engage, inspire and manage subordinate staff to achieve the same levels of excellence expected of yourself; Excellent communication skills, flexible attitude and capable of multi-tasking and working to tight deadlines under pressure; Excellent presentation skills with the ability to analyse and present data in a cohesive way; The ability to get on with and to influence people both internally and externally to achieve objectives; Clear thinker who can work independently and show leadership in managing and undertaking activities; Liaise with Manufacturing and Supplier Quality Manager to present Supplier Quality issues that may affect the Group. Other information As well as being dedicated to providing a great place to work in a rewarding, stimulating and environmentally conscientious environment, we offer an extensive range of benefits, listed below, and actively support learning and development opportunities for all: 25 days' holiday pa, rising to 28, plus bank holidays Compressed 4 day week & blended working options Enhanced pension scheme (with salary sacrifice option) Bonus schemes Sharesave scheme Mind & body wellbeing support Healthcare cash plan Retailer discounts Life assurance Enhanced and equal leave & pay for new parents Cycle to Work SmartTech scheme Electric Car Benefit Employee referral scheme Travel season ticket loan