Quality Engineering Manager

IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. The Quality Engineering Manager is responsible for managing the quality engineering activities for transfer to manufacturing and sustaining manufacturing in compliance with all applicable regulations and standards for medical devices.

SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES

• Provide manufacturing quality engineering leadership to manufacturing and sustaining engineering.
• Manage direct reports by providing direction, mentorship, and growth opportunities.
• Report on the Manufacturing and Quality KPIs.
• Conduct product design control activities for new and sustaining product development efforts.
• Support risk analysis activities, including design and process FMEA.
• Participate in quality-driven supply chain activities.
• Participate in the reliability customer complaint team meetings.
• Support Process Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities.
• Support Manufacturing Engineering in the creation of DMR, DHR, routers, bills of material, and specifications for in-house and external manufacturing.
• Prepare for and participate in internal and external audits with notified bodies and customers.
• Perform other duties as assigned to support the advancement of the QMS and product manufacturing.