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This is a highly responsible, independent and supervisory position responsible for all aspects of the quality improvement process. This position requires strong medical manufacturing, customer relations, organizational, and leadership skills as well as a working knowledge of quality control measures and quality control programs in an ISO 13485 environment.
1. Coach, mentor, develop, direct, train and evaluate the work of the quality improvement personnel.
2. Maintains a robust Quality Management System that meets all FDA and ISO 13485 requirements.
3. Ensure customer satisfaction with product quality.
4. Receive and provide communications and related materials / reportsregarding parts revisions, parts on hold, questions on dimensions, parts rejections, parts changes, qualifications, validations, internal audit data and other information required by the customer in regard to quality.
5. Receives, interprets and implements corrective action procedures as required by the customer in regard to product quality.
6. Implements changes in the process/procedures requirements to make changes and to improve product quality.
7. Oversees the internal audit and CAPA programs.
Responsibilities outlined in the Quality Floor Inspector, Quality Inspector and Quality Engineer job descriptions