Job Description
Job Description
About the role
You will manage the quality function by providing work direction for quality engineers and inspectors and interact regularly with engineering, manufacturing, and service functions to establish quality standards for raw materials, work in process, and finished products.
Key Responsibilities
This position operates on an on-site / hybrid work schedule (role-dependent).
- Formulate a strategy to foster a high-performance culture with quality right first time suitable for a world-class medical device contract and legal manufacturer.
- Coach and develop staff who support the quality function during the manufacturing process and drive a culture of quality awareness.
- Drive improvements to the quality system that ensures its suitability, adequacy, and effectiveness.
- Understand and ensure compliance with cGMP, ISO 13485, and FDA 21 CFR Part 820 regulations.
- Work closely with commercial and operati...