Quality Assurance Specialist

3 days ago

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

We are seeking a highly skilled Quality Assurance Administrator to join our team at Indo Search. As a Quality Assurance Administrator, you will play a crucial role in ensuring the quality and compliance of our medical devices.

Key Responsibilities
  • Drive Quality Excellence: Collaborate with cross-functional teams to drive quality excellence in product development and improvement.
  • Manage Design Control and Documentation Reviews: Ensure seamless design reviews and product releases, maintaining compliance across our range of Class IIa, IIb, and Class III sterile devices.
  • Oversee Quality Documentation: Manage quality documentation for new products, including material and sterilisation controls, to ensure ISO 13485:2016 compliance.
  • Maintain and Evolve the QMS: Collaborate with the Product Engineering and R&D teams to maintain and evolve the Quality Management System (QMS) and technical files as industry standards progress.
  • Support Release Processes: Oversee release processes for subcontracted production devices, ensuring quality and compliance.
Requirements
  • Experience with ISO Quality Systems: Proven experience with ISO quality systems in the medical device sector.
  • Knowledge of Design Control and Material Compatibility: In-depth knowledge of design control, material, and sterilisation compatibility processes.
  • Education and Certifications: Degree in physics, chemistry, engineering, or related field (preferred). Proficiency with eQMS systems and experience in managing design and change control under ISO 13485:2016.
  • Skills and Attributes: Self-motivated with excellent organizational and time management skills. Strong written and verbal communication abilities. Detail-oriented with a keen eye for accuracy. Adaptable team player comfortable in a fast-paced environment.
What We Offer
  • Competitive Salary: Up to £36,000 per annum.
  • Benefits Package: 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, and 2 volunteering days for charity work.

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