What are the responsibilities and job description for the Quality Assurance and Compliance Manager position at EPM Scientific?
About EPM Scientific
EPM Scientific is a growing ophthalmic medical device company seeking a quality assurance leader to join their organization in a crucial position. This role is vital for ensuring the highest standards of quality and regulatory compliance within the company.
Responsibilities
- Oversight of the company's quality system to ensure compliance with FDA, ISO, CE, and Health Canada certification regulations, including maintaining registrations with these entities.
- Serving as the Management Representative, keeping management updated on new regulations and the company's compliance status.
- Responsibility for regulatory compliance (PRRC), ensuring devices meet conformity standards, proper identification (UDI) before release, and managing post-market obligations.
- Handling customer complaints, including Medical Device Reporting and fulfilling Vigilance requirements.
- Management of activities and documentation related to Corrective/Preventive Actions.
- Oversight of the Document Control System.
- Monitoring environmental controls, equipment maintenance, calibration, and incoming inspection of parts and materials.
Requirements
- Bachelor's degree in a relevant field or equivalent work experience.
- At least five years of experience in a quality assurance role within the medical device environment.
- Strong organizational and time-management abilities.
- Proficiency in document management software and Microsoft Office.
