Quality Compliance Specialist in Bacup

We are currently recruiting for an experienced Quality Compliance Specialist to join an established business operating within the highly regulated medical device manufacturing sector.

This is an excellent opportunity for a quality professional with a strong understanding of ISO 13485 to play a key role in maintaining regulatory compliance, supporting quality management systems and driving continuous improvement across the business.

Working closely with the Quality Manager, you will help ensure that quality standards are consistently maintained, regulatory requirements are met and a proactive quality culture is embedded throughout the organisation.

• Maintain and continually improve the Quality Management System (QMS) in line with ISO 13485, ISO/IEC 17025 and FDA 21 CFR Part 820 requirements.

• Plan, conduct and report on internal quality audits.

• Support external audits, regulatory inspections and supplier audits, ensuring corrective actions are completed effectively.

• Manage key QMS processes, including document control, supplier approval and audit schedules.

• Identify compliance gaps, monitor regulatory changes and support the implementation of improvements.

• Investigate non-conformances, carry out root cause analysis and implement corrective and preventive actions (CAPA).

• Monitor quality performance, analyse trends and identify opportunities for continuous improvement.

• Create, review and maintain SOPs, work instructions and quality documentation.

• Support employee training and ensure accurate QMS training records are maintained.

• Liaise with internal departments and customers regarding quality, compliance and regulatory matters.

• Provide guidance and support to quality team members, including supervisory responsibilities where required.

• Previous experience in a quality or compliance role within the medical device industry.

• Strong working knowledge of ISO 13485 and Quality Management Systems.

• Experience conducting internal audits and supporting external regulatory inspections.

• Good understanding of CAPA, non-conformance management and root cause analysis.

• Knowledge of FDA 21 CFR Part 820, ISO 14971 and ISO/IEC 17025 would be advantageous.

• Experience reviewing and maintaining quality documentation and procedures.

• Strong analytical, problem-solving and organisational skills.

• Excellent communication skills, with the ability to work effectively across manufacturing, engineering and quality teams.

If you have experience in medical device quality compliance and are looking for your next opportunity, we would love to hear from you.

Apply today or get in touch for a confidential discussion about the role.