At a Glance
- Tasks: Lead quality management and regulatory compliance in a dynamic, quality-focused environment.
- Company: Join Xpert Recruitment Solutions Ltd, a leader in quality-critical business.
- Benefits: Competitive salary, hands-on experience, and opportunities for professional growth.
- Other info: Collaborative team culture with opportunities to support various operations.
- Why this job: Make a real impact by ensuring high-quality standards and improving processes.
- Qualifications: Experience in QA/RA and knowledge of ISO standards required.
The predicted salary is between 42750 - 52250 £ per year.
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.
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Quality & Regulatory Manager in Chesterton employer: XPERT RECRUITMENT SOLUTIONS LIMITED
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Contact Details:
XPERT RECRUITMENT SOLUTIONS LIMITED Recruitment Team
