What are the responsibilities and job description for the Quality Assurance/Training Supervisor position at EPM Scientific?
EPM Scientific is seeking a seasoned quality assurance professional to spearhead regulatory compliance within our organization. This critical role ensures the highest standards of quality and adherence to FDA, ISO, CE, and Health Canada certification regulations.
The ideal candidate will oversee the company's quality system, maintaining registrations with relevant entities and keeping management informed on new regulations and compliance status. As Management Representative, they will serve as the key point of contact for regulatory matters.
This leadership position involves:
- Ensuring devices meet conformity standards and proper identification (UDI) before release
- Managing post-market obligations and handling customer complaints, including Medical Device Reporting and Vigilance requirements
- Coordinating Corrective/Preventive Actions and overseeing the Document Control System
- Monitoring environmental controls, equipment maintenance, calibration, and incoming inspection of parts and materials
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. Strong organizational and time-management abilities are essential, as well as proficiency in document management software and Microsoft Office.
