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 Engineer Will support the Group Supplier Quality Assurance Team Lead with the quality compliance culture within the Group ensuring all staff are aware of the Companies' Business Management System and the need to adhere to it the requirements; Will be responsible for the management of supplier materials, working with suppliers to identify root causes and implementation of effective countermeasures in line with procedures, ISO 13485, Medical Device Single Audit Program (MDSAP) and Medical Device Regulation (MDR); Undertake a proactive approach with both internal stakeholders and suppliers to reduce the overall cost of poor quality. Responsible for the supplier performance and management program Assist with the Management of supplier Non-Conformances (including root cause investigations and CAPA) Consult with suppliers on quality issues from failures Lead desktop or on-site supplier audits - ISO13485:2016 and ISO9001:2015 To provide assistance during improvement activities The position also Includes maintaining the Companies Business Management System and ensuring compliance to all applicable regulations and standards; MAIN DUTIES AND RESPONSIBILITIES Ensuring 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); Supporting the promotion of supplier quality awareness of applicable quality requirements and Business Management System requirements throughout the Group; Support with the planning, scheduling and conducting internal audits and supplier audits; To 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 Business 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; Managing supplier concessions and SCAR's; Periodic review of supplier certification and documentation; To manage, with input from other key stakeholders and work streams, the Supplier Quality performance Score Card analysis; To input to Supplier Quality performance for Management Review and other Top Management reviews; To participate in the CAPA process; Travel to suppliers to perform supplier audits. MANAGEMENT RESPONSIBILITIES N/A 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; Working Knowledge in ISO 13485 and MDASP requirements; Working knowledge in Continuous improvement activities and problem-solving techniques. Desirable ISO13485:2016 Lead Auditor; Knowledge of Medical Device Directive and Medical Device Regulation. Knowledge of Advanced Product Quality Planning (APQP). 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 engage and deliver compelling presentations to a varied audience, and communicate and present a technical subject matter in an understandable, coherent manner; 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 accountability in managing and undertaking activities. Flexible and be able to work as part of a team, covering for other team members as appropriate. Excellent Verbal and Written Communication/ Interpersonal Skills. Meticulous/Attention to Detail. Proactive approach to issues and desire to initiate action as well as facilitating change. Excellent analytical and problem-solving skills. Ability to plan and prioritise assigned workload 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