What are the responsibilities and job description for the Medical Device Quality Manager position at EPM Scientific?
EPM Scientific is a leading provider of ophthalmic medical devices, and we are seeking a highly skilled quality assurance specialist to join our team.
In this critical role, you will be responsible for ensuring the highest standards of quality and regulatory compliance within our organization. This includes:
- Overseeing the company's quality system, including registrations with FDA, ISO, CE, and Health Canada
- Collaborating with management to stay informed on new regulations and compliance status
- Coordinating Corrective/Preventive Actions and managing post-market obligations
- Ensuring devices meet conformity standards and proper identification (UDI) before release
A Bachelor's degree in a relevant field or equivalent work experience is required, along with at least five years of experience in quality assurance within the medical device environment.
