Quality Management Systems Lead

12 hours ago


Guildford, Surrey, United Kingdom MV | MysteryVibe Full time

MV | MysteryVibe is a small but fast-growing medical device business dedicated to improving women's and men's healthcare. We are seeking a Quality Management Systems Lead to join our team and lead the development and implementation of our QMS for ISO 13485 certification.

About the Job

This role requires a strong understanding of quality management systems, ISO standards, and experience working with startups or small companies. The ideal candidate will have a background in medical devices, including OTC devices, QMS, or quality assurance.

Key Responsibilities
  • Develop and implement a QMS for ISO 13485 certification, particularly for Class II OTC medical devices.
  • Create and manage technical files, SOPs, risk management reports, and other documentation required for ISO 13485 certification.
  • Collaborate closely with product development and manufacturing teams to ensure alignment with quality and regulatory standards.

The successful candidate will receive a competitive salary range of $120,000 - $150,000 per annum, depending on experience, as well as opportunities for professional development and mentorship.



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