Establishing and implementing the process controls required to ensure compliance of the process and the product with all pertinent specifications and standards and monitoring compliance with the controls.
In this role, the selected candidate will be responsible for monitoring and supporting quality systems such as laboratory investigations, deviation management, CAPAs, instrument qualifications and change management.
The Quality Assurance (QA) Manager has the authority for and responsibility of developing, implementing, and improving the laboratory Quality System that meets the requirements set forth in the TestAmerica Quality Management Plan (QMP).
Monitor and assess trends of regulatory violations, and ensures that compliance issues/concerns within the organization are being appropriately evaluated, investigated, resolved and shared with a view of continuous learning.
In this role, you will develop tools for performance monitoring and provide feedback to the departments supported both formally (departmental presentations) and informally (shop floor review) and obtain agreement on corrective actions as required.
Responsible for managing Coopervisions global Quality Management System (QMS) Oracle Agile PLM. Assess the current QMS instance and develop a long term roadmap in alignment with our global QA organization. Manage the IS team supporting the application and new projects for ongoing improvements or enhancements.
In this role, you will leads a team of product/ process quality engineers, supplier quality engineers and quality inspectors directly accountable for supplier quality, incoming, in process and outgoing product quality for rochester facility.