Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). About the role: A senior member of the External Manufacturing Quality Engineering team performs a vital role in maintaining the highest levels of quality and compliance. This role will collaborate across organisational boundaries to both support new production commercialisation, life cycle management of existing base business at external manufacturers and also lead continuous improvement activities at external manufacturers at Convatec that assures continued product Quality and Regulatory compliance as well as driving the reduction of quality related issues. This role ensures the application of the appropriate controls, processes and review the enforcement of Good Manufacturing Practice (GMP) Standards within external manufacturers are maintained. Support quality initiatives and evaluate engineering elements instigating improvements where needed through problem solving and other quality system elements. The role is focused on driving towards right first time and the role will be a successful lead for external manufactured projects. This role will also support the Quality Manager, External Manufacturing and associated project teams/business units by providing oversight and guidance in External Manufacturing operations ensuring continuous GxP compliance and adherence to procedural requirements. Your key duties and responsibilities: Process Improvement & Methodologies • Active drivers of the use of structured problem-solving tools such as Lean, Six Sigma, and Kepner[1]Tregoe (KT) to drive continuous improvement and process development. • Lead drivers on how to Identify and implement opportunities for efficiency, quality, and compliance enhancements across product and process lifecycles. • Lead and Drive towards NPD with Process improvement and Cost of Quality focus. Third-Party Manufacturing Support • Collaborate with external manufacturing partners and T&I to ensure compliance with Quality Agreements and Delivery of NPD projects. • Participate in supplier site visits and audits to support project execution and quality assurance for LCM and NPD projects. Design Control & Risk Management • Lead and facilitate risk management activities (e.g., pFMEA, hazard analysis) throughout the product lifecycle, from development through post-market. Product & Process Validation • Contribute to the development and execution of validation protocols (IQ/OQ/PQ) for new and existing products and processes. • Support test method validation for in process checks and NPD development method to ensure critical[1]to-quality (CTQ) attributes are defined and controlled. Quality Engineering Support • Lead QEs to deliver projects and various workstreams. • Lead and perform statistical analysis, sampling plans, and capability studies to support product development and manufacturing. Cross-Functional Collaboration • Work closely with R&D, Manufacturing, Regulatory, procurement, and Supply Chain teams to ensure quality is embedded in all phases of product development and lifecycle management. • Lead cross-functional teams in implementing process improvements and resolving quality issues. Non-Conformance & CAPA Management • Investigate product and process non-conformances, customer complaints, and deviations using root cause analysis tools. • Develop and implement effective corrective and preventive actions (CAPAs) to prevent recurrence. Change Control & Post-Market Surveillance • Lead product and process change control activities, ensuring compliance with regulatory and internal requirements. • Support post-launch reviews and monitor product performance in the market using data-driven approaches such as PSURs etc. Auditing & Supplier Quality • Support internal and supplier audits to assess compliance with ISO 13485, 21 CFR Part 820, and other applicable standards. • Support supplier quality management activities including onboarding, performance evaluation, and SCAR resolution. Quality System & Compliance • Maintain and improve quality system documentation and processes to ensure regulatory compliance and alignment with site and corporate KPIs. • Promote a culture of quality and compliance across the organization. Skills : • Proficient in Design, Manufacturing and Third-party control processes and procedures. • Understand complaint handling systems in conjunction with 21 CFR 820 AND 803 as well as ISO 13485 MDSAP knowledge, ISO 9001, GMP Parts 201 and 211 • Knowledge and experience of TrackWise, PowerPoint and SAP. Preferably MINITAB. • Knowledge and experience in leading and managing changes internally and external • Strong knowledge skills on SAP and Validation procedures and processes. • Strong Interpersonal skills while experience in Cross functional deployment of projects. • A practical working knowledge of implementation of change control, and of all aspects of the process and computer systems validation lifecycle (preferred) • Demonstrated ability to lead multiple projects and motivate cross functional teams whilst ensuring that deadlines are met. Experience : • Minimum 5 years in a similar role, preferably within the medical device industry but not essential. • Strong knowledge and experience of CAPA and NC. • Competent auditor. Experience in hosting or acting as SME during external regulatory audits. • Experience in implementing/review of pFMEA. Qualifications/Education: • Degree or equivalent in science, engineering, or related discipline. • Six Sigma green belt qualified and / or demonstrated ability in the use of quality engineering tools and techniques (quality core tools) and data interpretation. • Regulatory and compliance knowledge of validation. • Knowledge and experience of working with a Quality Management System within Medical Device manufacturing. Travel Requirements: • The position may involve occasional travel up to 20%, both domestically and overseas. Most trips will include overnight travel. Working Conditions: • This role may be based in the UK with a remote working structure.