Manager

• Manage daily QC operations including in process checks during manufacturing and final release of imaging systems
• Responsible for QC testing including (system and software) verification and validation for design changes and manufacturing improvement
• Investigate and document nonconformances, deviations, and product defects; lead root cause analysis and corrective actions
• Define, maintain, and improve QC documentation and processes to meet U.S. FDA 21 CFR 820 (FDA QMSR), MDSAP, EU MDR, ISO 14971 and ISO 13485 requirements
• Testing for sub-assemblies and system level testing for finished products
• External safety testing for changes at system level, critical components and end of life parts
• Generate appropriate metrics to quantify product quality including maintaining analysis of failing components, subassemblies and other issues
• Facilitate failure analysis and field defect analysis along with trending information
• Serve as a liaison providing quality engineering expertise for continuous process improvements for engineering, service and manufacturing personnel
• Review and verify product labeling
• Work with and respond to inquiries from regulatory agencies and assist with audits and inspections
• Contribute directly or manage designee to product ship reviews
• Direct the Incoming Inspection process of first articles, populated board assemblies and cable assemblies
• Provide subject matter expertise to ensure deviations, CAPAs, product validation, equipment calibration, facility controls and change management meet regulatory requirements
• Assist with initiatives in the quality department to meet corporate goals and ensure compliance with medical device regulations
• Assist with preparing field action documentation and executing the field action process
• Promote teamwork and collaboration within the quality function and with other functional areas
• Facilitate risk management activities (RMF, Risk/Benefit, planning, etc.) as needed for all products to ensure compliance with regulating bodies
• Create updates for Management Review Meeting and communicate clearly with company personnel, vendors, regulatory agencies, auditors and customers as required

Quality Control Manager

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