Quality Engineer - QMS Processes

About Convatec

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). To learn more please visit

About 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:

Evaluate and enhance Quality Management System (QMS) processes to ensure they are scalable and effective across internal and external manufacturing sites.

Lead the harmonization of quality processes (e.g., CAPA, NC, change control, supplier quality, document control, complaint and PMS processes) to support multi-site manufacturing.

Develop and implement quality system metrics to monitor process performance and compliance across all sites.

Support qualification and ongoing oversight of the contract manufacturer, ensuring alignment with internal QMS expectations.

Facilitate cross-functional workshops to identify and close process gaps related to multi-site operations.

Ensure readiness for regulatory inspections and internal audits by maintaining robust and compliant QMS processes.

Act as a quality SME in tech transfer and scale-up activities, ensuring QMS processes support product lifecycle requirements.

Authority (if applicable):

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 Engineering

Skills & Experience:

Experience within medical device and /or pharma industry

Deep understanding of QMS frameworks (ISO 13485, 21 CFR 820, EU MDR)

Expertise in process mapping, gap analysis, and process improvement

Strong knowledge of CAPA, change control, NC, supplier quality, audit readiness, PMS etc.

Experience with QMS integration across multiple sites, including external partners

Familiarity with quality metrics and KPIs

Strong project management and stakeholder engagement skills

Qualifications/Education:

A master’s or bachelor’s degree in engineering, chemistry, biology, pharmacy or equivalent

Travel Requirements

Position may involve travel up to 10% of the time

Languages:

English - Fluent

Working 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.

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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.

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Convatec 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.

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