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).
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.
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.
Review and approve MBR/EBR/Deviations/Process and Cleaning Validation protocols/Reports/Equipment Qualification Reports and reports and communicates any changes to the Validation Master Plan in a timely manner.
Provide leadership of the Crosstex Medical Division Quality Assurance Team; lead quality assurance support to Manufacturing Operations by ensuring timely release of product, resolving quality related issues, improving product quality and investigating customer complaints.
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.
Monitor measure and report on compliance and control activities and key quality indicators across the organization. Analyze and identify issues impacting operational performance and establish initiatives for continuous improvement.
Ensure all supplier non-conformances are identified and managed in a timely manner to minimize risk to the company and are documented to maintain a history of supplier performance, with preventive action implemented robustly at the source of the root cause.