Job Title: Quality Assurance Specialist
Company: MV | MysteryVibe
We are seeking a highly skilled Quality Assurance Specialist to lead the development and implementation of our Quality Management System (QMS) for ISO 13485 certification. The ideal candidate will have a strong background in medical devices, quality assurance, and ISO 13485 standards.
Responsibilities:
* Lead the development and implementation of the 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.
* Serve as the main point of contact for external auditors and certification bodies.
* Stay up-to-date on ISO 13485 standards and regulations and ensure compliance with 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.
Requirements:
* 5+ years of experience with medical devices, including OTC devices, QMS, or quality assurance, with a strong interest in developing ISO 13485 expertise.
* Previous experience working in a startup or small business is a plus.
* Experience in technical writing and maintaining documentation for medical devices, preferably Class II products, is a plus.
* Ability to work independently in a fast-paced environment, with 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 including comprehensive private medical insurance.
* The opportunity to take on a leading role in building a QMS from the ground up.
* A flexible, inclusive, and dynamic work environment.
* Professional development and mentorship, with guidance directly from founders and senior professionals in engineering and medicine.
How to Apply:
Please submit your resume and a brief cover letter outlining your experience with quality management systems, ISO standards, and working with startups or small companies to [insert contact information].