Quality Assurance Supervisor
A growing ophthalmic medical device company is 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.
Role and Responsibilities
- Oversee the company's quality system to ensure compliance with FDA, ISO, CE, and Health Canada certification regulations, including maintaining registrations with these entities.
- Act as the Management Representative, keeping management updated on new regulations and the company's compliance status.
- Serve as the person responsible for regulatory compliance (PRRC), ensuring devices meet conformity standards, proper identification (UDI) before release, and managing post-market obligations.
- Handle customer complaints, including Medical Device Reporting and fulfilling Vigilance requirements.
- Manage activities and documentation related to Corrective/Preventive Actions.
- Oversee the Document Control System.
- Conduct internal audits and facilitate audits by external entities.
- Monitor environmental controls, equipment maintenance, calibration, and incoming inspection of parts and materials.
Experience and Qualifications
- 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.
- Two years of supervisory experience preferred.
Skills and Knowledge
- In-depth understanding of ISO 13485 and FDA regulations.
- Strong organizational and time-management abilities.
- Leadership skills.
- Proficiency in document management software and Microsoft Office.
