Quality Engineer

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

Participate in changes within the project portfolio in Convatec ensuring compliance with internal and external requirements according to standards, customer, and authorities; ensuring quality system is developed, maintained, and improved; assuring Process Validation and CCR system is followed accordingly and supporting as leader on quality issues or non-conformities raised from the project-change

Key responsibilities

• Contribute to the development and execution of validation protocols (e.g. 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-toquality (CTQ) attributes are defined and controlled.
• Supporting business unit in assuring compliance with internal and external requirements according to 
  standards, customers and authorities. 
• Support external and internal audits as applicable.
• Support, participate and perform statistical analysis, sampling plans, quality control plans and capability 
  studies to support product development and manufacturing.
• Act as a support for process FMEAs and validation strategies, ensuring robust design and smooth transfer to 
  manufacturing.
• Work closely with key stakeholders like R&D, Manufacturing, Regulatory, and Supply Chain teams to ensure 
  quality is embedded in all phases of product development and lifecycle management.
• Support, participate, lead cross-functional teams in implementing process improvements and resolving quality 
  issues.
• Apply structured problem-solving tools such as Lean and Six Sigma, to drive continuous improvement and 
  process development

Requirements

• Bachelor's degree in engineering or related careers.
• Minimum 2+ years in a similar role, preferably within the medical device industry but not essential.
• Regulatory and compliance knowledge of validation.
• Knowledge and experience of working with a Quality Management System within Medical Device manufacturing.
• English proficiency: Intermediate - Advanced.
• Microsoft Office proficiency: Intermediate - Advanced.

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