Quality Assurance Manager

Are you an experienced Quality Assurance professional looking for a hands on leadership role in a fast-paced environment? We are seeking a Quality Assurance Manager to support a leading provider of gamma sterilisation services within the medical device and healthcare industry.

About the Role:

This is a key quality leadership position within a smaller, specialist operation, offering a fantastic opportunity to make a real impact. You will be responsible for maintaining and improving quality systems, ensuring compliance with ISO 13485, ISO 9001, and 21 CFR Part 820, and leading a small quality team of two.

Key Responsibilities:

• Oversee and maintain the Quality Management System (QMS) in compliance with medical device and sterilisation regulations
  
  
• Manage audits, CAPA investigations, non-conformances, and document control
  
  
• Act as the primary quality contact for internal and external stakeholders, including regulatory bodies and customers
  
  
• Support continuous improvement initiatives to enhance quality and efficiency
  
  
• Provide hands on leadership to a small team, ensuring training and development
  
  Who We’re Looking For:
  
  
• Experience in quality assurance within medical devices, pharmaceuticals, or sterilisation
  
  
• Knowledge of gamma sterilisation processes (preferred, but not essential)
  
  
• Strong understanding of ISO 13485, ISO 9001, 21 CFR 820, and regulatory compliance, comfortable working in a smaller, fast-paced operation
  
  
• Some leadership or supervisory experience (doesn’t have to be extensive)
  
  Why Apply?
  
  
• Work in a specialist industry with a growing demand for sterilisation services
  
  
• Make a direct impact in a key quality leadership role
  
  
• Join a tight-knit team where your contributions are highly valued
  
  Interested? Apply today or contact us for more details