Medical Quality Manager at Hear.com
hear.com is the fastest-growing hearing care company globally. We are driven by our belief that every person should hear well to live well. With our unique digital business model, we have changed the way hearing care is provided. We are a profitable global health-technology company with origins in Europe. Since starting our journey in 2012, we have helped over 100,000 customers get on the path to better hearing. In just 8 years, we have grown our team from 2 to over 1,000 people. We work hard and play hard in 11 international locations from Miami to Seoul. We promise to ourselves: to define the future of hearing care, to never be corporate and to always live Day One.
We are looking for a Medical Quality Manager to further strengthen our Teleaudiology team here in the U.S.
Join us now, as we are shaping this fascinating consumer healthcare space!
- Implement a Quality Management System for software as medical device in accordance to ISO13485
- Provide management and oversight to the QMS once implemented for products on the market and new products in development
- Discuss inspection results with those responsible for products; and recommend necessary corrective actions.
- Achieve quality goals through planning, coordinating, and supervising quality activities
- Act as an advisor and distributor of knowledge on current FDA regulatory requirements
- Oversee internal and external quality audits and review findings with management
- Develop corrective action plans for non-conforming product and develop process improvements
- 5+ years of related QA experience managing vendors within the medical device space
- Good and current knowledge of FDA regulatory requirements
- Knowledge of the regulatory requirements of the EMA and other international institutions is a plus
- Strong communication and interpersonal skills
- Strong organizational skills and attention to detail
- Previous experience in software engineering is a plus
What we offer:
- An opportunity to work with happy and grateful customers every single day
- A chance to shape the future of a health-technology leader
- A unique content-driven, top-performing and family-type work culture
- A high degree of autonomy and responsibility from day one
- An open-minded and international working environment that fosters creativity
- Excellent salary and benefits package with entrepreneurial incentives