Senior Quality Assurance Specialist

3 weeks ago


Cambridge, Cambridgeshire, United Kingdom Northreach Full time

Northreach is a dynamic recruitment agency that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth. We have partnered with a global Biotech firm that help ensure that new scientific discoveries can be translated quickly into patient care using a variety of technologies, platforms

We are seeking a skilled Quality Process Specialist to support our transition from ISO 9001 to ISO 13485 and drive best practices in quality management. This role is key in shaping and implementing robust quality processes within our organization.

Key Responsibilities:

  • Lead the transition from ISO 9001 to ISO 13485, ensuring compliance and best practices.
  • Develop and implement key quality procedures, such as Risk Management, Design Review, and Test Strategy.
  • Train and support staff to ensure adoption of new quality processes.
  • Oversee the integration of quality processes across sites and partner companies, including coordinating documentation and defining audit scopes.
  • Collaborate with Procurement to establish appropriate quality standards for suppliers and engage with key vendors to ensure compliance.
  • Work closely with the internal quality team to manage and mitigate quality risks.

What We're Looking For:

  • Strong experience in quality management within regulated industries (preferably medical devices).
  • Knowledge of ISO 13485 and its implementation.
  • Ability to develop and roll out effective quality processes.
  • Experience in supplier quality management and cross-site integration.
  • Excellent communication and training skills.

This is a great opportunity to make a real impact on quality processes in a forward-thinking organization. If you have the expertise and enthusiasm to help drive this transition, we'd love to hear from you



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