The role involves leading quality improvement efforts for legacy products and continuous improvement initiatives to ensure customer satisfaction
Job Summary
The role involves leading quality improvement efforts for legacy products and continuous improvement initiatives to ensure customer satisfaction.
Candidates will be responsible for developing risk management plans, writing validation protocols, and utilizing statistical tools like Six Sigma to improve process capability.
The position requires supporting vendor audits, investigating corrective actions, and assisting regulatory affairs with submissions for new processes and devices.
Matching Summary
The role involves leading quality improvement efforts for legacy products and continuous improvement initiatives to ensure customer satisfaction.
Skills & Requirements
Must-have
Bachelor's degree in related field
4-6 years quality or manufacturing experience
Knowledge of GMP and QSR requirements
Experience with design control and V&V tools
Ability to apply Six Sigma and DOE methodologies
Nice-to-have
Master's degree preferred
Knowledge of GD&T
Lean manufacturing experience
ASQ certification
Process Excellence tools knowledge
Key Requirements
Bachelor's degree required
4-6 years experience in medical device industry
Thorough knowledge of GMP and QSR
Six Sigma and Business Excellence tools understanding