Quality Assurance Specialist

5 hours ago


Guildford, Surrey, United Kingdom MV | MysteryVibe Full time
Lead Compliance Specialist for ISO 13485 Certification

We are seeking a highly skilled Lead Compliance Specialist to join our team at MV | MysteryVibe. As a key member of our quality assurance department, 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.

  • Perform internal audits and continuous process improvements for ISO 13485 compliance.
  • Train and educate internal teams on quality management processes and regulatory compliance.
  • Work alongside manufacturing teams to ensure quality and compliance are maintained across the product lifecycle.

**Salary:** $120,000 - $150,000 per year, depending on 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.


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