The Company MV.Health is an award-winning leader in women’s & men’s health devices. We create clinically proven medical devices that adapt to the user's body & deliver targeted vibrations to address Genito-Pelvic pain, penetration pain, arousal disorder & erectile dysfunction. Our devices are recommended by leading doctors at Mayo Clinic, Cedars-Sinai & Veterans Affairs and have changed the lives of over 200,000 users worldwide. Position Overview: We are embarking on getting ISO 13485 certification. To lead that, you will be responsible for creating and managing the necessary documentation and processes for ISO 13485. You’ll collaborate with cross-functional teams across the company and external suppliers to build all the documentations and processes required for ISO 13485. You will lead the submissions process and coordinate all the activities required to get ISO 13485. Ongoing, your role will be to focus on internal Quality Assurance and ensure all documentation and processes are up to date. This is a fantastic opportunity for someone looking to have full ownership of Quality assurance and processes in a small and fast-growing medical device business, making a huge impact on women’s and men’s healthcare. Key Responsibilities: Lead the development and implementation of the QMS for ISO 13485 certification, particularly for Class II OTC medical devices. Create & manage technical files, SOPs, risk management reports & other documentation required for ISO 13485 cert. Collaborate closely with product development and manufacturing teams, ensuring alignment with quality and regulatory standards. Serve as the main point of contact for external auditors and certification bodies, while receiving guidance from the company’s senior leadership. 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. Work alongside the manufacturing teams to ensure quality and compliance are maintained across the product lifecycle. Qualifications: 7 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. Previous experience working in a small company or startup environment is highly beneficial. 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 a plus. 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. Hybrid working opportunities after an initial onboarding period. 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 careersmysteryvibe.com.