Quality Assurance Supervisor

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.