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 Quality Controller will be responsible for the quality inspection process in line with the Business Management System and for ensuring compliance with ISO 13485, Medical Device Single Audit Program (MDSAP), and other regulations in which the Companies sell their products. Main Duties and Responsibilities Perform product release inspection of our products to ensure compliance to quality and safety requirements; Perform production batch review (Device History Records) to ensure the product meets the required test specifications before release; Perform final release (goods out inspection) of the product including relevant accessories ensuring the complete shipment meets the customer requirements; Provide relevant quality documents required for each shipment; Perform in-process inspection, identify and report any non-conformity, and maintain the quarantine area on a daily basis; Raise Non-Conformities(s) and provide support for the root cause analysis and corrective / preventative actions; Support Production Engineering with applicable process improvement activities; Support Calibration and Asset Management process if required. Management Responsibilities None Requirements Experience and Qualifications Required Mandatory Previous experience in a Quality Controller role in a Medical Device organisation; A demonstrable knowledge in ISO 13485 and MDASP requirements. An engineering/technical background and the ability to read engineering drawings Desirable Certified internal auditor/ auditing experience; Awareness of Medical Device Directive and Medical Device Regulation. Key Skills and Competencies A demonstrable and broad understanding of medical device manufacturing; 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 product quality knowledge and expertise in different markets; 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 other Quality Assurance and Regulatory Affairs team members to present 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