Quality Engineer - Design Control

About ConvatecPioneering 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). To learn more please visit http://www.convatecgroup.comAbout the role:Quality Engineer role manages the performance of the Engineering aspects of the site’s Quality System and Quality Control processes in achieving all established user requirements and all applicable regulatory agency requirements. The role ensures compliance with Corporate Quality System procedures during Process Development, Design Transfer, Process Validation, Launch and Engineering Change activities. Collaborates with internal suppliers and customers to establish product quality requirements.Key Responsibilities: Ensure that design control documentation (e.g., DHF, DMR, DHR) is complete, consistent, and compliant across all manufacturing sites, including the contract manufacturer.Act as the primary liaison between R&D, manufacturing, and quality teams to align design outputs with site-specific capabilities and regulatory requirements.Lead gap assessments and remediation activities to ensure design documentation supports manufacturing at each site.Maintain traceability between design inputs, risk management, verification/validation, and manufacturing process controls.Support change control processes to ensure updates to design documentation are effectively implemented across all sites.Collaborate with regulatory affairs to ensure documentation supports global submissions and compliance.Authority:Review and approve documents on behalf of PQE’s (Product Quality Engineers) and Design Assurance Engineers.Review and approve documents on behalf of Team Lead – Quality EngineeringSkills & Experience: Experience within medical device and /or pharma industry (5+ years)Strong knowledge of design control principles (21 CFR 820.30, ISO 13485)Expertise in DHF, DMR, DHR structure and maintenanceProficiency in risk management (ISO 14971) and traceability matricesExperience with multi-site design transfer and documentation alignmentFamiliarity with product lifecycle management (PLM) systemsStrong technical writing and documentation review skillsAbility to interpret and apply regulatory requirements across jurisdictionsA master’s or bachelor’s degree in engineering, chemistry, biology, pharmacy or equivalentTravel RequirementsPosition may involve travel up to 10% of the timeLanguagesSpeaking: EnglishWriting/Reading: EnglishWorking Conditions:3-5 days per week in the office driven by business requirements, as Convatec has a flexible approach to office working.Ready to join us? At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life.Beware of scams online or from individuals claiming to represent ConvatecA formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com.Equal opportunities Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.Notice to Agency and Search Firm RepresentativesConvatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Already a Convatec employee?If you are an active employee at Convatec, please do not apply here. 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