Senior Quality Systems Manager – Medical Devices (ISO 13485)

Entrepreneur First; City of London; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading medical technology firm in London is seeking a Quality System Manager to take ownership of their Quality Management System. This role requires compliance with international medical device regulations, including ISO 13485:2016 and EU MDR 2017/745. The ideal candidate will have over 5 years of experience in quality leadership, with skills in risk management and documentation control. The position requires 4 days a week in the office and offers various benefits including a company equity plan and unlimited holiday allowance.

Benefits

Company equity plan

Company pension scheme

Private medical, dental and vision insurance

Group life insurance

Comprehensive mental health support

Unlimited holiday allowance

Weekly lunches

Breakfast and snacks provided

Qualifications

• 5+ years’ experience in medical device quality or QMS leadership.
• Deep knowledge of ISO 13485:2016, 21 CFR Part 820, and EU MDR 2017/745.
• Demonstrated success preparing for and managing audits.
• Strong working knowledge of risk management and CAPA.
• Excellent written and verbal communication skills.

Responsibilities

• Champion the Quality Management System and maintain compliance.
• Establish and maintain high-quality documentation processes.
• Lead the management review process with clear metrics.
• Plan and execute internal and external audit programmes.
• Oversee CAPA and nonconformance activities.
• Support supplier qualification and performance management.
• Maintain and develop the Quality Training Programme.
• Promote a culture of quality across the business.

Skills

Medical device quality leadership

ISO 13485:2016 compliance

Regulatory inspections management

Risk management (ISO 14971)

Documentation control systems

Written and verbal communication

Collaborative relationship building

Job description

A leading medical technology firm in London is seeking a Quality System Manager to take ownership of their Quality Management System. This role requires compliance with international medical device regulations, including ISO 13485:2016 and EU MDR 2017/745. The ideal candidate will have over 5 years of experience in quality leadership, with skills in risk management and documentation control. The position requires 4 days a week in the office and offers various benefits including a company equity plan and unlimited holiday allowance.