Quality Assurance and Compliance Specialist

2 weeks ago


Guildford, Surrey, United Kingdom MV | MysteryVibe Full time

MV | MysteryVibe is seeking a skilled Quality Assurance and Compliance Specialist to lead the development and implementation of our Quality Management System (QMS) for ISO 13485 certification.

Key Responsibilities:

  • Develop and implement QMS processes and procedures for Class II OTC medical devices.
  • Collaborate with cross-functional teams to create and manage technical files, SOPs, and risk management reports.
  • Ensure alignment with quality and regulatory standards for product development and manufacturing.
  • Serve as the main point of contact for external auditors and certification bodies.
  • Stay up-to-date on ISO 13485 standards and regulations, ensuring ongoing compliance.
  • Perform internal audits and continuous process improvements for ISO 13485 compliance.
  • Train internal teams on quality management processes and regulatory compliance.

Requirements:

  • 5+ years of experience with medical devices, including OTC devices, QMS, or quality assurance.
  • Strong interest in developing ISO 13485 expertise.
  • Previous experience working in a startup or small business is a plus.
  • Excellent project management and problem-solving skills, with strong communication abilities.

What We Offer:

  • Competitive salary and benefits package.
  • Opportunity to take on a leading role in building a QMS from the ground up.
  • Flexible and inclusive work environment.
  • Professional development and mentorship.


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