Quality System Coordinator - Medical Devices

Quality Systems Coordinator - 3 to 6 Month Contract (Onsite in Falmouth, Cornwall)

A leading medical devices site is seeking a skilled Quality Systems Coordinator for a 3 to 6 month onsite contract in Falmouth, Cornwall. The successful candidate will manage and maintain the Quality Management System (QMS) and support compliance with ISO 13485, FDA 21 CFR Part 820, and MDSAP standards.

Key Responsibilities:

QMS Management:

• Create, implement, and maintain quality procedures and documentation.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, MDSAP, and other regulatory standards.

CAPA & Non-Conformance Oversight:

• Manage CAPA processes including initiation, investigation, and resolution.
• Monitor timelines, track effectiveness, and report progress.

Audit Support:

• Assist with internal and external audits, including preparation and follow-up.
• Act as deputy in Management Review meetings.

Continuous Improvement:

• Identify process improvement opportunities and track key performance indicators.

Qualifications:

• Minimum 2 years' experience in Quality Assurance, preferably in the Medical Devices industry.
• In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and MDSAP.
• Experience in CAPA management, auditing, document control, and continuous improvement.
• Proficient with Master Control and Microsoft Office.
• Excellent communication and interpersonal skills; native-level English proficiency.

This role offers a unique chance to drive quality excellence at a key site. If you have a strong quality background and are ready to make an impact in a fast-paced, collaborative environment, apply now to join this exciting 3 to 6 month opportunity in Falmouth, Cornwall.

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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