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Certification Expert in Quality Management Systems

1 month ago

Guildford, Surrey, United Kingdom MV | MysteryVibe Full time
ISO 13485 Quality Assurance Lead

We are seeking an experienced ISO 13485 Quality Assurance Lead to join our quality assurance department at MV | MysteryVibe. As a key member of our team, you will be responsible for leading the development and implementation of Quality Management Systems (QMS) for ISO 13485 certification.

This role requires close collaboration with product development and manufacturing teams to ensure alignment with quality and regulatory standards. You will serve as the main point of contact for external auditors and certification bodies, receiving guidance from senior leadership. Staying up-to-date on ISO 13485 standards and regulations is crucial for ongoing post-certification requirements.

  • Develop and maintain technical files, Standard Operating Procedures (SOPs), risk management reports, and other documentation required for ISO 13485 certification.
  • Collaborate closely with product development and manufacturing teams to ensure quality and regulatory standards are met.
  • Perform internal audits and continuous process improvements for ISO 13485 compliance.

**Estimated Annual Salary:** $140,000 - $170,000, based on industry standards and your experience.

Requirements:

  • 5+ years of experience with medical devices, including OTC devices, QMS, or quality assurance, with a strong interest in developing ISO 13485 expertise.
  • Experience working in a startup or small business is a plus.
  • Technical writing and documentation experience for medical devices, preferably Class II products, is a plus.
  • Excellent project management and problem-solving skills.
  • Strong communication skills, with the ability to collaborate across teams.

**What We Offer:

  • Competitive salary and benefits package.
  • Flexible, inclusive, and dynamic work environment.
  • Professional development and mentorship, with guidance from founders and senior professionals.
  • Hybrid working opportunities.