Description:
PRIMARY PURPOSE:
Lead and develop a large organization of quality professionals with varied backgrounds and experience. Plan and manage activities concerned with the development, application and maintenance of quality standards for manufacturing processes, materials and products. Manage and plan the activities of the quality engineering group, with the main objective of optimizing product performance and controlling the manufacturing process. Develop and implement strategies to integrate quality assurance into every aspect of our business systems.

Experience:
EDUCATION and/or EXPERIENCE:
Bachelor’s degree in Statistics or Engineering; 10-14 years experience in the medical device industry; a minimum of five years experience in quality engineering function and 3-5 years supervisory experience; or equivalent combination of education and experience. ASQ CQE certification preferred. Experience in Process Optimization and Variability Reduction/Cost Reduction Projects required. Experience with new product development preferred. Regulatory knowledge specific to the FDA Quality System Regulations, ISO9001/ISO13485, and the Medical Device Directive (MDD) required as well as experience with regulated complaint handling systems, including returned goods processing and analysis.