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
* Internal auditing experience
* 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.
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