Job Description

Quality System Coordinator (6-Month Fixed-Term Contract)

Location: Falmouth, Cornwall (4 days on-site, 1 day WFH)

Salary: £30,000 - £35,000 (depending on experience)

Are you an experienced Quality System professional with a background in the medical device industry? Do you have a passion for maintaining high-quality standards and ensuring compliance with international regulations? If so, we have a fantastic opportunity for you!

We are looking for a Quality System Coordinator to join a global IVF and reproductive genetics company based in Falmouth, Cornwall. This is a 6-month fixed-term contract role with a focus on maintaining and managing the Quality Management System (QMS), supporting the Quality Manager, and ensuring compliance with ISO 13485, FDA 21 CFR Part 820, and MDSAP standards.

Key Responsibilities:

Support QMS activities: Assist in the creation, implementation, and maintenance of QMS to meet ISO 13485, FDA 21 CFR Part 820, MDSAP, and relevant regulations.

CAPA Process: Help initiate, investigate, and implement corrective and preventive actions (CAPAs), ensuring timely resolution and tracking effectiveness.

Non-Conformance Management: Maintain accurate records, perform trend analysis, and identify recurring issues through NCMRs.

Audit Support: Prepare for and support internal and external audits, ensuring all documentation is up-to-date and compliant.

Continuous Improvement: Identify opportunities for process improvements and track progress to meet quality objectives.

Collaboration: Work closely with cross-functional teams and global stakeholders to align site-specific activities with global standards.

Reporting: Generate reports and presentations for management reviews and audits related to CAPA, NCMRs, and Continuous Improvement.Key Skills & Qualifications:

Knowledge of regulatory standards: Solid understanding of ISO 13485, FDA 21 CFR Part 820, MDSAP, and EU Medical Device Regulations.

Experience in Quality Systems: Minimum 2 years of experience in Quality Assurance, including document control, auditing, and CAPA management.

Technical Skills: Proficient in Master Control and Microsoft Office Suite.

Attention to Detail: Strong organizational and problem-solving skills, with a results-driven mindset.

Audit Experience: Hands-on experience in auditing and knowledge of GMP.Why Join Us?

£30,000 - £35,000 depending on experience.

Flexible work environment: 4 days on-site and 1 day working from home.

Be part of a dynamic, global company focused on cutting-edge IVF and reproductive genetics.

Contribute to maintaining high standards of quality in an essential field.If you have the skills and experience we are looking for, and you're ready to make an impact in a world-leading company, we'd love to hear from you! Apply now to join the team as a Quality System Coordinator.

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

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