Job Description
MV | MysteryVibe is an award-winning leader in women's and men's health devices, creating clinically proven medical devices that adapt to the user's body. We deliver targeted vibrations to address Genito-Pelvic pain, penetration pain, arousal disorder, and erectile dysfunction.
The company offers a competitive salary of $120,000 - $150,000 per year, along with benefits including comprehensive private medical insurance. Our dynamic work environment provides opportunities for growth and professional development, with guidance directly from founders and senior professionals in engineering and medicine.
Position Overview:
We are embarking on getting ISO 13485 certification, requiring the creation and management of necessary documentation and processes. You will lead cross-functional teams across the company and external suppliers to build required documentations and processes for ISO 13485. Your role will be to focus on internal Quality Assurance, ensuring 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 and manage technical files, SOPs, risk management reports, and 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, receiving guidance from the company's senior leadership.
* Stay up-to-date on ISO 13485 standards and regulations, ensuring 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:
* 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.