The Area Quality Assurance Manager manages and coordinates quality assurance activities of varying risk and complexity across multiple sites or customers. The role communicates quality policies and procedures, serves as an expert on selected governmental regulations, and acts as a proactive quality assurance liaison to customers. It leads a defined group of QA resources and key initiatives, communicates regulatory and corporate policy changes, develops and implements site policies and procedures, and oversees site quality managers and coordinators. The role also leads global and cross-sector QA initiatives and develops and implements processes for regulated hardware, equipment, and software systems, validating them as applicable. The manager oversees maintenance and continuous improvement of quality systems across multiple sites or customers, including management reviews, CAPA, internal audits, self-assessments, change control, document control, and operating procedures and work instructions. Responsibilities also include licenses, permits, registrations, validation and change control processes, regulatory compliance oversight, audit support, quality metric analysis, customer engagement, management reporting, supplier assessment, and coordination of audits. The role works with continuous improvement teams to direct improvement activities and workshops. Approximately 25% travel is required.
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Job Type
Full-time
Career Level
Manager