The Quality Engineer plans, coordinates, and directs the applicable areas of the Quality Management System designed to ensure continuous production of products consistent with established standards to include FDA, cGMP, ISO and company standards.
- Ensure compliance with appropriate regulatory standards & customer specific requirements.
- Perform and coordinate internal or supplier audits/training to ensure continuing compliance with Quality System Standards and the manufacture of safe products.
- Conduct statistical analysis of production processes and reporting of findings.
- Improve Quality processes for increased efficiency and reduction of factory escapes.
- Initiate and assist with containment activities internally and externally to establish product clear point and ensuring shipment of certified product to customers.
- Promote the application of error proofing solutions by challenging root cause and corrective actions.
- Provide technical expertise for development and maintenance of suppliers and systems.
- Responsibilities may also include training employees; planning, assigning and directing work; addressing complaints and resolving problems.
Background/Experience: Four-year technical college degree (Engineering preferred) and 3+ years experience in regulated quality systems in a manufacturing environment to include medical device, pharmaceutical or biologics. Proficiency with MS Office required. Ability to read, analyze, and interpret blueprints, technical procedures and governmental regulations.