Quality Systems Engineer

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.

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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 xwzovoh 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.