Quality & Regulatory Manager

Xpert Recruitment Solutions Limited; Chesterton; On-site; GBP 60,000 - 90,000; Full time

Job summary

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

Qualifications

• 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.

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.

Skills

Quality Assurance

Quality Management

Quality & Regulatory Affairs

Audits

CAPA

Root cause analysis

Record-keeping

Job description

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.