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Interim Quality Systems Specialist – Medical Devices (ISO 13485)
Contract
Start Date: ASAP
We are supporting a growing medical device organisation seeking an experienced Quality Systems Specialist to provide immediate support during a period of transition. This is an opportunity for a hands-on quality professional who enjoys operational QMS activities, maintaining compliance, and supporting teams through ISO 13485 certification readiness.
Working closely with the Quality team, you will play a key role in maintaining and improving the Quality Management System, ensuring documentation remains accurate, controlled, and audit-ready.
Looking for 2 - 6 years experience
Key Responsibilities:
- Support the day-to-day operation and maintenance of the Quality Management System (QMS)
- Manage controlled documentation, including updates, reviews, approvals, and document lifecycle activities
- Support ISO 13485 certification readiness activities and continuous improvement initiatives
- Maintain and improve eQMS processes and workflows
- Support CAPA, non-conformance, deviation, and change control activities
- Ensure quality records are complete, accurate, and compliant with regulatory requirements
- Assist with internal audits, compliance reviews, and quality system improvements
- Work collaboratively with cross-functional teams to embed effective quality processes
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Requirements:
- Proven experience working within a medical device environment
- Strong experience with ISO 13485 Quality Management Systems
- Hands-on experience supporting QMS operations, documentation control, and quality processes
- Experience using an eQMS platform (experience with SaaS-based systems such as KUNAI/Klara or similar is highly desirable)
- Comfortable working operationally within a small quality team
- Strong attention to detail with the ability to manage documentation and system updates effectively
- Available to start at short notice
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Desirable Experience:
- Previous involvement in ISO 13485 certification preparation or maintenance
- Experience with CAPA, change controls, audits, and continuous improvement
- Ability to work independently in a fast-moving regulated environment
This role would suit a Quality Engineer, Quality Specialist, QA Specialist, or QMS Coordinator who enjoys being close to the detail and making a practical impact within a medical device quality function.
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