Quality Engineer

Cure Talent are delighted to be supporting a pioneering medical device manufacturer based in South-West London. As they continue to expand their global reach, we have an exciting opportunity for a Quality Engineer to join their growing QA/RA team.

This business designs and manufactures their own innovative wound and infection treatment device on-site. With approvals already in place across Europe and expansion into new markets underway, this is a great time to join a forward-thinking organisation making a real-world impact.

As the new Quality Engineer, you will play a hands-on role across the Quality Management System, design controls, technical documentation, audits, and post-market activities. You'll be part of a small, experienced team working closely across functions including manufacturing, purchasing and regulatory.

You’ll need a solid grounding in Medical Device Quality Assurance combined with proven knowledge of ISO 13485, risk management, and medical device compliance. The role offers variety and visibility, with opportunities to learn, take ownership, and contribute to the continued success of a breakthrough technology.

Key Responsibilities:

• Maintain and improve the Quality Management System in line with ISO 13485.
  
  
• Own and update technical documentation and risk management files.
  
  
• Conduct internal audits and support external inspections.
  
  
• Collaborate with design and manufacturing teams on product development and change control.
  
  
• Support product registrations and global compliance activities.
  
  
• Contribute to post-market surveillance activities and continuous improvement.
  
  About You:
  
  
• Degree in a biomedical, engineering or related discipline.
  
  
• Proven experience in a Quality Assurance role within Medical Devices.
  
  
• Solid understanding of ISO 13485, ISO 14971 and EU MDR requirements.
  
  
• Internal audit experience (external audit exposure desirable).
  
  
• Proactive, detail-oriented, and keen to work in a fast-moving SME environment