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.
Responsible for the consistent and correct execution of QS global procedures within the site to ensure the quality and compliance of processes and records for Change Control, Records Management, CAPA, NC, Customer Complaints Investigations, QPR and QSMR and Filed Action Investigations.
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.
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.
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.
Primary liaison for testing resources and support to Business Acceptance Testing (BAT), Performance Testing, Automation Testing and Warranty support.Responsible for Resource forecasting, allocation and utilization.