Quality Engineer - Projects

A medical device / life sciences organisation is seeking a Quality Systems Engineer to support and maintain key Quality Management System (QMS) processes within a regulated environment. This role will take ownership of core quality processes including: Document Control Change Control Failure Investigations / Root Cause Analysis The position works closely with cross-functional teams including Production, Engineering, Regulatory Affairs, R&D, and Supply Chain to ensure compliance with ISO 13485 and FDA quality standards. The successful individual will play a key role in maintaining accurate documentation, supporting audits, driving quality improvements, and ensuring robust investigation processes across manufacturing and operational activities. Key Responsibilities Manage document control activities across the full document lifecycle Maintain and administer electronic document management systems (eDMS/eQMS) Coordinate and facilitate change control processes and assessments Lead product and process failure investigations using structured RCA methodologies (5-Why, Fishbone, FMEA, 8D etc.) Support external audits and regulatory inspections Promote a quality-focused culture across the organisation Collaborate with multiple departments to ensure compliance and process improvement initiatives are delivered effectively Ideal Background Experience within medical device, IVD, pharmaceutical, or highly regulated environments Strong understanding of ISO 13485, GMP, and/or 21 CFR Part 820 Experience with document management systems and quality systems processes Ability to manage investigations, documentation, and cross-functional activities independently Strong communication and organisational skills Desirable Experience Internal auditing experience Lean / Six Sigma exposure Risk management and validation knowledge Experience supporting regulatory inspections and technical documentation This opportunity would suit someone looking to take ownership of critical QMS activities within a growing and quality-focused environment.