Overview
Responsible for the launch and daily management of the processes, products, equipment, people, and customers in regard to the quality management system and regulatory requirements.
Responsibilities
- Team lead for the organizational onsite requirements for the quality management system
- Development and implementation of all quality related processes and documentation for current and new business
- Direct involvement in manufacturing process development as to meet or exceed the companies quality metrics and process metrics for current and new business
- Monitoring the facilities overall performance and associated metrics and responsible for creating and implementing plans to achieve metric targets
- Development and implementation of preventative actions and continuous improvements within the manufacturing and quality areas
- Coordinate with the quality inspector for the daily inspection, measurement, test, and approval of all components, product, process and use of quality metrics to ensure quality targets are met.
- Work closely with Engineering Department and Operations Department to perform Validation activities (IQ/OQ/PQ)
Requirements
- Engineering bachelor’s degree or diploma, with technical and mathematical focus preferred.
- 5 years’ experience in a quality department in an ISO registered environment - medical device manufacturing preferred
- Medical Product validation experience is essential
- Experience with machining, fabrication, and assembly operations a plus
- Six Sigma certifications a plus (green belt or higher)
