Sr. Manager of Quality and Regulatory – Extron

PLYMOUTH, MN

The Sr. Manager of Quality and Regulatory will provide quality management and regulatory affairs leadership across the business. The will provide strategic direction, training, and support across the organization.

Responsibilities and Duties:

• Develop, administer, and maintain quality assurance procedures and activities.
• Responsible for ensuring the business activities are conducted in compliance with the regulations and standards applicable to our business and the needs of our customers.
• Responsible for planning and hosting external quality audits/inspections of our facilities.
• Ensure all business processes are fully supported by appropriate documentation.
• Perform batch record reviews, in-process final release audits and dispositions of final product to assure procedural adherence of the organization
• Assist in the preparation for and conducting of internal and external audits.

• Develop, establish, implement and maintain the processes needed for the quality system to function effectively.
• Review all change orders, deviations, incident reports, NCR?s and CAPA?s.
• Coordinate with other heads of departments, integrating objectives and ideas for organizational growth of the business.
• Perform day-to-day administrative tasks, such as processing information files and other paperwork
• Manage and coordinate all services related to Return Material Authorization (RMA?s), on-site technical support activities, client technical questions, etc.
• Supervise quality assurance specialist and quality coordinator.