Quality Assurance Specialist

2 days ago


Cambridge, Cambridgeshire, United Kingdom Indo Search Full time £36,000
About the Role

We are seeking a highly skilled Quality Assurance Administrator to join our team at Endomag, a pioneering company in surgical guidance technology for breast cancer. As a key member of our Product Engineering and R&D teams, you will play a crucial role in ensuring the quality and compliance of our Class IIa, IIb, and Class III sterile devices.

Key Responsibilities
  • Drive quality excellence in product development and improvement
  • Manage design control and documentation reviews, ensuring ISO 13485:2016 compliance
  • Oversee quality documentation for new products, including material and sterilisation controls
  • Maintain and evolve the QMS and technical files as industry standards progress
  • Support release processes for subcontracted production devices
  • Collaborate across departments to uphold quality standards and regulatory compliance
Requirements
  • Experience with ISO quality systems in the medical device sector
  • Knowledge of design control, material, and sterilisation compatibility processes
  • Degree in physics, chemistry, engineering, or related field (preferred)
  • Proficiency with eQMS systems
  • Experience in managing design and change control under ISO 13485:2016
What We Offer
  • Competitive salary up to £36,000 per annum
  • 9% non-contributory pension
  • Up to 10% bonus
  • Private medical insurance for you and your family
  • Private dental insurance
  • 25 days holiday plus an annual buy scheme for an extra 5 days
  • 2 volunteering days for charity work
  • Structured training for career development
About Endomag

Endomag is a leading company in surgical guidance technology for breast cancer, with innovative solutions transforming patient care in over 600 hospitals across 40+ countries. Recently acquired by Hologic, Endomag is poised for even greater impact and growth.



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