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Director of Quality Assurance
2 months ago
We are seeking a seasoned quality leader to join our team as the Director of Quality. This pivotal role will lead all quality-related teams and activities, driving product quality improvement efforts while serving as a key member of the factory leadership team.
Responsibilities:- Lead factory ramp up and efficient production processes, including site validation activities and supplier quality assurance.
- Drive improvements to product quality, maintaining a strong GEMBA orientation and culture of accountability and continuous improvement.
- Facilitate and develop constructive relationships with customers, operations, and other business entities.
- Ensure QMS compliance, implementing quality management systems to support certification by regulatory bodies.
- Lead root cause analysis of complex systems issues, evaluating changes to products and proposing organizational or systems changes to address changing business and customer needs.
- Bachelor's degree in Quality or STEM-related discipline with 10+ years experience, and 5 years management experience, or a Master's Degree in a related discipline.
- 10 years experience and 5 years management experience, or an equivalent combination of education and experience.
- Demonstrated QMS and audit expertise for Medical Device and Combination products and knowledge of applicable standards.
- Extensive knowledge of U.S. and international medical device regulations and standards.
We provide competitive total reward offerings, including compensation, benefits, recognition, and a wealth of other well-being, work-life, and recognition programs. Our benefits include multiple group medical, dental, and vision plans, a robust wellness program, life insurance, and disability coverages, as well as a variety of voluntary programs.
We are committed to protecting the personal welfare of our associates and their families, helping to achieve personal goals, and offering those extra touches for convenience, security, and overall peace of mind.
