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.
#J-18808-Ljbffr”, “datePosted”: “2026-05-17”, “hiringOrganization”: { “@type”: “Organization”, “name”: “Kinara Group”, “sameAs”: “https://uk.whatjobs.com/pub_api__cpl__435485031__4861?utm_campaign=publisher&utm_medium=api&utm_source=4861&geoID=31” }, “jobLocation”: { “@type”: “Place”, “address”: { “@type”: “PostalAddress”, “addressLocality”: “City of Edinburgh” } } }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.
#J-18808-Ljbffr…