Quality Manager

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Position Summary :

The Quality Manager oversees HUI's quality management system to assure compliance with the ISO 9001 : 2015, 13485 : 2016, and FDA standards. This position works closely with HUI customers and suppliers on problem resolution and the implementation of corrective actions. The Quality Manager also works very closely with representatives from each team for internal auditing, inspections, root cause analysis, and corrective action implementation.

Responsibilities :

• Key measures that this position is responsible for : Internal, External and Supplier PPM
• Championing HUI's Quality Journey and Quality Management System
• Leading the ISO Management Review meeting.
• Assisting customer and 3rd party quality management system auditors as HUI's management representative.
• Establish department policies, control processes and quality programs.
• Looking at trends in defect data and finding opportunities for improvement.
• Assisting in vendor performance evaluation.
• Providing technical support to all aspects of the organization.
• Overseeing the communication of customer specifications.
• Facilitating quality discussions in huddles and info share.
• Provide coaching to quality team and HUI internal personnel as needed.
• Facilitating the use of risk management and problem-solving tools that include but are not limited to PFMEA, A3, & 5why.

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