Job Summary

• This position plays a key technical role in leading and supporting the effective execution of the sites’ Quality Management System (QMS), with a primary focus on the governance and execution of the Change Control process.
• The role requires strong technical expertise to assess, advise on, and support changes impacting validated systems, manufacturing processes, equipment, software, and quality documentation, ensuring appropriate risk assessment, validation strategy, and regulatory compliance.
• The individual will partner closely with Engineering, Manufacturing, IT, Validation, and Regulatory stakeholders, and liaise with Franchise, Sector, and Enterprise teams to drive harmonization, standardization, and simplification across Change Control and other key QMS processes and systems.

Matching Summary

Skills & Requirements

Key Requirements

• Bachelor's degree in Science, Engineering or related discipline
• Six (6) years of professional experience in Quality
• Experience in medical device or pharmaceutical manufacturing
• Technical experience in change control and validation systems/processes
• Advanced knowledge of ISO 13485:2016, 21 CFR 820

Work Rights