Quality System Coordinator - Medical Devices

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.

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