Xpert Recruitment Solutions Ltd is recruiting a proactive, hands-on Quality & Regulatory Manager to take ownership of the Quality Management System (QMS) and regulatory compliance within an established, quality-critical business.

This role would suit an experienced QA/RA professional who can maintain high quality standards while working collaboratively across the business. Alongside quality responsibilities, you will support wider operations, including goods-in, stock control and warehouse activities when required.

Key Responsibilities

• Manage and continually improve the QMS in line with ISO 9001 and/or ISO 13485.

• Maintain quality documentation, procedures and records.

• Investigate customer complaints, supplier issues and product non-conformances.

• Lead root cause analysis and corrective and preventive actions (CAPA).

• Conduct internal audits and support external certification and customer audits.

• Manage supplier quality, incoming goods inspections and product traceability.

• Ensure compliance with relevant quality standards and regulatory requirements.

• Identify opportunities for continuous improvement.

• Provide quality guidance and training to colleagues.

• Support purchasing, goods-in, stock control and warehouse operations when required.

Essential Requirements

• Experience in Quality Assurance, Quality Management or Quality & Regulatory Affairs.

• Practical knowledge of ISO 9001 and/or ISO 13485.

• Experience managing or maintaining a QMS.

• Understanding of audits, non-conformance management, root cause analysis and CAPA.

• Strong organisational, communication and problem-solving skills.

• Excellent attention to detail and accurate record-keeping.

• A flexible, practical and team-focused approach.

Desirable

• Experience in medical devices, healthcare products or regulated manufacturing.

• Internal or lead auditor qualification.

• Knowledge of UK and EU medical device regulations.

• Experience with supplier audits, risk management, change control or ERP systems.

This is an excellent opportunity for a quality professional seeking a varied role combining technical QA/RA expertise with a practical, hands-on contribution to the wider business.

Apply today to find out more.

Xpert Recruitment Solutions Ltd is acting as an employment business on behalf of our client. By applying, you agree to register with us and consent to us holding your personal details on file. Due to the high volume of applications, only shortlisted candidates will be contacted. We may also contact you regarding other suitable vacancies that match your profile.