Develops and administers divisional quality and design assurance programs. Interacts with manufacturing, engineering, and other managers to direct the efforts of quality assurance personnel in implementing quality assurance programs. Drives continuous improvement of process and product quality and performance.
Develops quality control goals, objectives, and action plans involving product and process quality improvements. Develops quality specifications, testing procedures, and standards for materials, processes, and finished products and administers quality programs in support of divisional products.
Defines quality assurance objectives, assigns responsibilities, delegates work assignments, and monitors performance of subordinates. Collaborates with other managers to insure cohesive divisional quality assurance efforts. Maintains communication with other departments to insure proper priority of efforts.
Develops and administers process evaluation and control programs. Uses statistical analysis and other methods required to measure process performance.
Investigates defective products and non-conforming materials. Recommends modifications to product, process, or quality standards when warranted. Develops and executes recovery plans. Leads quality assurance efforts through participation in design reviews, establishment of appropriate design history files and other technical files, and development of integrated quality plans to cover quality assurance activities associated with new product introduction. Ensures management activities associated with product quality assurance are performed. Leads product verification and validation efforts. Coordinates compliance and certification issues with corporate quality assurance and regulatory affairs personnel.
Acts as divisional representative in internal and external audits. Leads corrective action efforts. Responsible for divisional customer complaint and corrective and preventive action systems. Ensures compliance with applicable standards and regulations.
Prepares and presents periodic reports on quality issues, activities, and systems. Provides internal updates and status to management. Communicates with customers to address and resolve quality issues, reviews product reliability, and establishes product improvement programs. Supplier qualification, including site visits, may be required.
BSEE or equivalent and eight years of related experience.
Knowledge of ISO standards; federal Quality Systems Regulations (QSR), including good manufacturing practices; and industry-specific requirements such as Medical Device Directive (MDD) and Canadian requirements for medical systems (CMDCAS).