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 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.
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.
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.
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.