We are seeking a proactive, detail-oriented and hands-on Quality & Regulatory Manager to take ownership of the quality management system and regulatory compliance within an established business operating in a quality-critical environment.

This is an excellent opportunity for someone with a strong background in Quality Assurance and Regulatory Affairs (QA/RA).

The successful candidate will take responsibility for maintaining and continually improving the Quality Management System (QMS), ensuring that products, suppliers and business processes meet the required quality standards and regulatory obligations.

However, this is not simply a desk-based quality management role. We are looking for someone who is comfortable rolling up their sleeves, working collaboratively with colleagues across the business and taking a practical approach to resolving problems.

As part of a close-knit team, you will be expected to get involved in wider operational activities when required. This may include supporting purchasing, goods-in processes, stock-related activities and warehouse operations, particularly during quieter periods within the quality function.

Key Responsibilities

Quality Management System (QMS)

• Maintain, manage and continually improve the Quality Management System in accordance with ISO 9001 and/or ISO 13485 requirements.
• Maintain controlled quality documentation, including policies, procedures, work instructions and records.
• Ensure quality processes are practical, effective and consistently followed throughout the business.
• Identify opportunities to improve processes, product quality and operational efficiency.
• Provide quality guidance and training to colleagues, promoting a positive culture of quality and compliance.

Quality Assurance and Non-Conformance Management

• Investigate customer complaints, product issues and quality concerns, ensuring timely resolution.
• Lead root cause investigations and manage corrective and preventive actions (CAPA).
• Monitor recurring issues and implement improvements to prevent their reoccurrence.
• Manage supplier quality issues and work with suppliers to resolve non-conformances.
• Establish and maintain appropriate incoming goods inspection procedures.
• Ensure non-conforming products or materials are correctly identified, documented and managed.

Audits and Compliance

• Plan and conduct internal quality audits.
• Coordinate external certification audits and customer audits, where required.
• Ensure audit findings and corrective actions are addressed effectively and within agreed timescales.
• Maintain accurate quality records and ensure documentation is readily available for audit purposes.
• Monitor relevant quality standards and regulatory requirements, supporting ongoing compliance.
• Maintain appropriate regulatory and product documentation, including traceability and technical records where applicable.

Supplier and Customer Quality

• Support supplier approval, assessment and ongoing performance monitoring.
• Investigate supplier-related issues and obtain appropriate corrective action responses.
• Communicate professionally with customers regarding complaints, investigations and resolutions.
• Work closely with purchasing and operational colleagues to resolve quality issues efficiently.
• Ensure appropriate product specifications, certifications and supporting documentation are maintained.

Operational and Team Support

• Work closely with colleagues across the business to support the smooth running of day-to-day operations.
• Take a practical, hands-on approach to incoming goods inspection, product checks and quality-related activities.
• Assist with warehouse and stock-related activities when required, particularly during quieter periods.
• Be willing to support other projects and general business activities where appropriate.
• Identify opportunities to improve working practices, reduce inefficiencies and strengthen processes across the business.

Essential Skills and Experience

• Previous experience in a Quality Assurance, Quality Management or Quality & Regulatory Affairs role.
• Practical experience working with ISO 9001 and/or ISO 13485.
• Experience maintaining or managing a Quality Management System.
• Experience investigating customer complaints, supplier issues and product non-conformances.
• Understanding of root cause analysis, corrective and preventive actions (CAPA) and continuous improvement.
• Experience with internal audits, quality documentation and controlled procedures.
• Strong attention to detail and the ability to maintain accurate records.
• Good organisational skills, with the ability to manage priorities and work independently.
• Confident communication skills and the ability to work effectively with colleagues, customers and suppliers.
• A practical, solutions-focused approach and a willingness to get involved in hands-on activities.
• A flexible, team-oriented attitude and a willingness to support wider business operations when required.

Desirable Experience

• Experience within medical devices, healthcare products, regulated manufacturing or a similar quality-critical environment.
• An internal auditor or lead auditor qualification in ISO 9001 and/or ISO 13485.
• Knowledge of applicable UK and EU medical device regulatory requirements, where relevant.
• Experience supporting external audits, supplier audits and management reviews.
• Familiarity with supplier management, product traceability, change control and risk management.
• Experience working with ERP systems or electronic quality management systems.

This role would suit a quality professional who wants to retain ownership of quality and regulatory responsibilities while becoming more involved in the wider operation of a business.

We are looking for someone who can combine technical quality expertise with a hands-on, team-focused approach and who is keen to make a meaningful contribution to the wider business.

If you have a strong QA/RA background, take pride in maintaining high standards and enjoy a practical role where no two days are necessarily the same, we would be interested in hearing from you.

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, we will only contact candidates who have been shortlisted for the role. However, we may also reach out regarding other suitable vacancies that match your profile.