QA MANAGER- Healthcare

The QA Manager is responsible for maintaining the quality systems strategy and providing coordination and direction of existing quality programs to ensure production of products, services, and processes are consistent with established standards.

Requirements

• Developing and overseeing execution of companies audit plans/strategies.
• Process and evaluate audit findings to monitor overall compliance and to identify quality related trends/issues, areas of business and/or regulatory risk, and training needs
• Provide consultation on regulatory compliance issues
• Ensure performance and quality of products and services conform to established company and regulatory standards.
• Host external regulatory agency and notified body assessments and inspections (example: FDA, ISO). Review and participate in issues and/or decisions related to assessments.
• Maintain the biological and chemical waste management programs to ensure compliance to Local, State and DOT regulations.
• Act as a customer interface during on-site audits, conference calls and other standard means of communication.