Quality Assurance and Compliance Specialist
2 weeks ago
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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