Company Overview
MV | MysteryVibe is a leading innovator in women's and men's health devices. Our clinically proven medical devices adapt to the user's body, delivering targeted vibrations to address Genito-Pelvic pain, penetration pain, arousal disorder, and erectile dysfunction.
We are committed to changing lives with our products, recommended by top doctors at Mayo Clinic, Cedars-Sinai, and Veterans Association, having impacted over 150,000 users worldwide.
Salary and Benefits
This role offers a competitive salary and comprehensive benefits package, including private medical insurance, to support your well-being and career growth.
About the Job
We are seeking an experienced Quality Assurance Specialist to lead the development and implementation of our Quality Management System (QMS) for ISO 13485 certification. This is an exciting opportunity to build a QMS from the ground up and drive quality assurance across our product lifecycle.
Key Responsibilities
* Lead the development and implementation of the QMS for ISO 13485 certification, focusing on 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 primary point of contact for external auditors and certification bodies, receiving guidance from senior leadership.
* Stay up-to-date on ISO 13485 standards and regulations, ensuring ongoing post-certification compliance 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 maintain quality and compliance across the product lifecycle.
Qualifications and Requirements
* 5+ years of experience in 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 beneficial.
* Experience in technical writing and maintaining documentation for medical devices, preferably Class II products, is advantageous.
* 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.
* Experience in quality engineering or working closely with manufacturing teams is desirable.
Benefits and Opportunities
We offer a dynamic and inclusive work environment, providing opportunities for professional growth and mentorship directly from founders and senior professionals in engineering and medicine.
After an initial onboarding period, you will have the flexibility to work remotely, allowing you to balance your work and personal life effectively.
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.