As a global market leader in the world of eyecare, Keeler’s dynamic business creates an exciting opportunity for career development. We are a vibrant, future-facing organisation, with over a century of industry expertise. The highly-trusted Keeler brand supports our consistent revenue growth. We actively foster a diverse, inclusive work environment and continuously seek to drive sustainability across our organisation. Keeler is a part of Halma, a global group of life-saving technology companies focused on growing a safer, cleaner, healthier future for everyone, every day. Employing over 7,000 people in more than 20 countries, Halma has major operations in the UK, mainland Europe, the USA and Asia Pacific. Halma is listed on the London Stock Exchange (LON: HLMA) and is a constituent of the FTSE 100 index. Halma plc is a global group of life saving technology companies. We provide innovative solutions to many of the key problems facing the world today, and anticipate solutions needed in the future. As a result, for over 50 years, our science and technology push the boundaries of what’s possible. Headquartered in the UK, Halma is a FTSE 100 company with a current market capitalisation of circa £9.4bn (November 2024). It is one of the top performing businesses in the FTSE index with over 20 successive years of record revenues and profits. In the financial year to April 2024, it generated revenue of circa £2,034m and profit before tax of £424m. It has increased its dividend by at least 5% every year for the last 40 years – an achievement unrivalled by any company quoted on the LSE. With almost 50 businesses in 24 countries and major operations in Europe, the USA and Asia, Halma employs over 8,500 people worldwide and serves customers in over 160 countries. Its companies and products are diverse, and have a core focus on health, environment, and the safety markets. Find out more about us at www.halma.com and www.keeler.co.uk About the role The Quality Management System (QMS) Engineer takes full ownership of the areas of Keeler Quality Management System, as assigned by the UK QMS & CI Lead. The role owns the management and drives the improvements in assigned areas. The role pro-actively supports the rest of the QA/RA team and wider business with issues related to overall quality assurance, control and compliance. As well as maintaining ISO14001:2015 (Environmental Management System) certification. QMS: Support quality driven technology driven projects. Development and update of QMS procedures and associated Work Instructions and documentation Compliance to ISO 13485:2016 and/ or Medical Device Single Audit Programme (MDSAP), FDA and other global requirements Usage of Quality Investigational tools e.g. Five Whys Technique, Fish Bone Technique, Pareto, FMEA, Is/Is Not Analysis, Ishikawa, FMEA to identify the true root cause of an event. Manage, Maintain, and Implement CAPAs (Corrective and Preventative Actions) Development of flowcharts to improve QMS process understanding Continuously improving processes to promote more agile workflows Participation in the review and approval of processes Conduct gap analysis for standards and regulations Provide QMS Induction training for new starters Prepare training files for new starters File completed training records on a monthly basis Preparation and delivery of monthly KPI presentations/ Metrics reporting Contribute to product Risk Assessment Providing support and guidance in the development and implementation of quality management systems Providing support and guidance in the development and implementation of quality management systems AUDITS: Plan and conduct internal and supplier audits, ideally as an ISO 13485:2016 Internal Auditor Co-host Notified Body, regulatory authority and customer audits (with QSM/SRAO) Plan and conduct Design History File and Device Master Record audits OPERATIONS: Advising on technical matters relating to product safety and performance Working with other teams to assess problems and determine root cause, corrections and corrective actions Advising on supplier quality issues Management of packaging label system including updates to templates, images and database, and development of new templates, images etc Oversight of Concessions and Reworks in Operations DESIGN & DEVELOPMENT: Experience in providing Quality Assurance support for New Product Development, Implementation and Launch Training of cross functional teams in using advanced quality planning tools, such as DFMEA, PFMEA, PPAP and others Review and approval of quality assurance activities and deliverables in new product development projects Participation in cross-functional product development teams as the quality representative Providing input to Risk Management during product development phase Support device testing activities (IEC 60601-1, 60601-1-2 etc) Assist in preparation of Technical Files DESIGN CHANGE: Experience in change control processes Attend weekly Design Change meetings as QA/RA representative Design Change signatory and processing of Change Notes COMPLAINTS: Investigation and documentation of safety-related complaints (CAPA & Incident Reports) Overseeing complaint analysis and reporting complaint trends Incident reporting to regulatory authorities Product evaluation & testing Customer liaison and response ENVIRONMENTAL: Maintain compliance with ISO14001 (Environmental Management System) Driving continuous improvement project with a focus on Sustainability KEY KNOWLEDGE & EXPERIENCE: Experience and working knowledge of Quality Assurance Substantial experience in the Medical Device Manufacturing and Healthcare Industry Usage of Quality Investigational tools e.g. Five Whys Technique, Fish Bone Technique, Pareto, FMEA, Is/Is Not Analysis, Ishikawa, FMEA to identify the true root cause of an event. Sound knowledge of CAPAs (Corrective and Preventative Actions) Lead Auditor trained and certified Ability to confidently provide QA support across the business Working in a medical device manufacturing environment Working knowledge of ISO 13485:2016, MDSAP, Medical Devices Directive (93/42/EEC) and Medical Devices Regulations (EU) MDR 2017/745 Unique Device Identification (2013/172/EU) Knowledge of IEC 60601 standards, particularly 60601-1 (Electrical Safety), 60601-1-2 (EMC) and 60601-1-6 (Usability) Experience with Risk Management to ISO 14971 Ability to work independently on key projects and mentor other members of the team Strong communication skills and ability to influence internal stakeholders and external customers and suppliers with strong analytical reasoning and demonstrate a hands-on approach to work Must be a team player and capable of participating with commitment and sense of ownership. 1 to 2 years’ experience maintaining ISO14001certification About You KEY ATTRIBUTES: Attention to detail Planning and organisation Confident presenter Technical competence Problem solving skills Team working Self-reliant Excellent communicator Excellent report writing skills Working to deadlines High standards Numerically competent, with an understanding of statistics. Competent with MS Office, Word, PowerPoint, Outlook, Excel etc. What We Offer You Competitive Remuneration Package including base Salary, performance related bonus structure, pension scheme, and other associated benefits. The potential to work in collaborative work environment within Keeler and Halma Group Career Development Opportunities within Keeler and Halma Group Location of the role is Windsor based, with working from home hybrid model. LI-SL2 Join us in creating and delivering life-changing products and solutions that impact millions of people around the world, helping our customers bring an end to preventable vision loss.