Responsibilities
• Lead the QA/RA function and drive organizational excellence •
Work with other functions to implement and maintain programs and processes to ensure highquality products and compliance with ISO 9001
• Oversee the maintenance and improvement of an ISO 9001-compliant Quality System
• Create, revise, review, and approve quality-related documents, including but not limited to procedures, memoranda, protocols, batch records, and reports
• Support the creation of incoming QC methods and supervise their performance
• Supervise the reviews of manufacturing, and quality control data for in-process and finished products to comply with relevant standards
• Responsible for the enforcement of quality standards and process controls
• Responsible for the management and coordination of training, equipment calibration, and maintenance programs
• Responsible for the customer complaint, non-conformance and CAPA processes, and MRBs
• Lead the supplier evaluation and approval process
• Lead and participate in the management reviews of the quality system. Elicit input from other departments
• Lead the preparation, coordination, and management of inspections and audits
• Elicit cooperation from cross-functional team members in assuring readiness for, and responses to, audit findings
• Oversee, review, and approval of product design control process and documents
• Maintain a working knowledge of applicable government and industry quality standards
• Multitask and manage competing priorities while meeting production timelines
