Quality supervisor Jobs in Philadelphia, PA

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

Skills and Knowledge