Quality Manager – Medical Device/Pharma

About the role

We are seeking an experienced Quality Manager to join the site leadership team of a leading medical device and pharmaceutical manufacturing organisation. This senior position will oversee the Quality function, ensuring compliance with stringent regulatory standards while driving operational excellence and continuous improvement.

Key responsibilities

• Lead, develop and mentor the site Quality team.
• Define and implement the site’s quality strategy and improvement plans.
• Maintain and continuously improve the Quality Management System.
• Ensure compliance with ISO 13485, FDA Quality System Regulations, GMP and customer requirements.
• Manage quality budgets, reduce risk and cost.
• Act as site Management Representative and lead Management Review activities.
• Drive CAPA processes and root‑cause investigations.
• Oversee customer complaints and quality issue resolution.
• Lead internal audit programmes and support external audits.
• Maintain effective change control processes.
• Develop and report quality KPIs, trends and performance metrics.
• Promote a strong “quality first” culture across the organisation.

Required profile

• Degree in Engineering, Science or a related discipline.
• 5–8 years of quality leadership experience in medical devices or a similarly regulated manufacturing environment.
• Proven ability to lead quality teams and drive performance.
• Strong problem‑solving and root‑cause analysis capability.
• Excellent stakeholder management and communication skills.

Required skills

• ISO 13485
• FDA Quality System Regulations
• GMP
• ISO 14971
• CAPA processes
• Six Sigma
• Continuous Improvement methodologies
• Certified Quality Auditor qualification (desirable)

What we offer

• Senior leadership position within a reputable organisation.
• Competitive salary and benefits package.