Operations Quality Lead — Quality, CAPA & Compliance

CMR Surgical; Ely; On-site; GBP 70,000 - 95,000; Full time

Benefits offered by this job

Bonus

Pension

Healthcare

Parental leave

Job summary

CMR Surgical in the United Kingdom is seeking an experienced Head of Operations Quality to lead quality, safety and regulatory compliance across the supply chain, manufacturing, and service. You will develop the team, strengthen prevention and drive CAPA with evidence-based decisions.

The role requires hands-on leadership, risk management, calibration controls and traceability, and collaboration with Operations Engineering and Regulatory to ensure compliant production and ongoing improvements.

Qualifications

• Leadership experience in team management, change, cross-training and development.
• Experience developing cross-functional problem management systems and root-cause investigations.
• Inspection, measurement equipment and statistical expertise.
• Strong communication, relationships and influence with colleagues, suppliers and customers; cross-team project delivery.
• Commercial awareness and budget management.
• Lean Six Sigma and ISO 13485 auditing qualifications.

Responsibilities

• Lead Operations Quality to meet quality, safety and regulatory requirements and develop the team.
• Lead inspection, assurance and nonconformance across supply chain, manufacturing, test, logistics, repair and service with QMS responsibilities.
• Manage lifecycle nonconformance, product-issue and material review processes, with CAPA and root-cause analysis.
• Partner with Operations Engineering, Production and Repair on risk management and process controls.
• Maintain QMS controls, audit readiness, change control and data integrity, with trained staff evidence.
• Escalate risks within delegated Quality authority and coordinate with Regulatory and Corporate Quality.

Skills

Leadership experience

Quality management

Inspection equipment

Statistics

Cross-functional collaboration

Budget management

Lean Six Sigma & ISO 13485 auditing

Tools

Calibration equipment

Job description

CMR Surgical in the United Kingdom is seeking an experienced Head of Operations Quality to lead quality, safety and regulatory compliance across the supply chain, manufacturing, and service. You will develop the team, strengthen prevention and drive CAPA with evidence-based decisions.

The role requires hands-on leadership, risk management, calibration controls and traceability, and collaboration with Operations Engineering and Regulatory to ensure compliant production and ongoing improvements.