Mike Fales Email & Phone Number | A solutions-oriented quality management leader who has successfully developed and deployed risk-based quality systems with an emphasis on maximizing the customer experience through lean efficient quality processes that focuses on agility and prevention. Successful track record of partnering across the entire organization including executive leadership, leading diverse teams, analyzing risks, implementing changes, and resolving product quality concerns expressed by customers, regulatory agencies, and European Notified Bodies. Impactful professional partnering with executive management and leading quality and engineering functional teams and cross discipline project teams. Core competencies include: Cross Functional Team Leadership Organizational Development Staff Coaching Medical Devices and Combination Product Quality Systems Development and Deployment Strategic and Tactical Quality Planning Design Control Safety Risk Management Field Action Determination and Implementation Human Usability System Interoperability Lean and Agile Principles Quality and Reliability Metrics and Improvement CAPA and Nonconformance Management Post Market Surveillance Cybersecurity and Privacy Software Quality Master Validation Planning Production and Process Control Service Quality Change Management Electronic Document Management Systems Resource Allocation Global Regulatory Compliance Internal Quality Systems Auditing Supplier Management Regulatory and Customer Audit Management Electronic Learning Management Systems

Mike Fales

A solutions-oriented quality management leader who has successfully developed and deployed risk-base...
Crystal Lake, Illinois, United States

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Mike Fales’s Email fales@cvs.com

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Mike Fales’s Location Crystal Lake, Illinois, United States

Mike Fales’s Current Industry Fresenius Kabi Usa

Mike Fales’s Prior Industry Cvs Health | Ge Healthcare | Baxter Healthcare | Plasco

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Work Experience

Fresenius Kabi Usa

Director, Quality Assurance and Vigilance

2023-11-01 00:00:00 - Present

Cvs Health

Head of Quality Management, Training, and Compliance CVS Health Kidney Care HemoCare

2021-05-01 00:00:00 - 2023-07-01 00:00:00

Ge Healthcare

Sr. Risk Manager, Regulatory Affairs / Quality Assurance

2009-08-01 00:00:00 - 2021-05-01 00:00:00

Baxter Healthcare

Program Director / Peritoneal Dialysis Systems Support Team Leader

2009-02-01 00:00:00 - 2009-08-01 00:00:00

Plasco

Quality/Regulatory Director

1986-07-01 00:00:00 - 1988-05-01 00:00:00

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FAQ About Mike Fales

Mike Fales is located at
Crystal Lake, Illinois, United States

Mike Fales is a A solutions-oriented quality management leader who has successfully developed and deployed risk-based quality systems with an emphasis on maximizing the customer experience through lean efficient quality processes that focuses on agility and prevention. Successful track record of partnering across the entire organization including executive leadership, leading diverse teams, analyzing risks, implementing changes, and resolving product quality concerns expressed by customers, regulatory agencies, and European Notified Bodies. Impactful professional partnering with executive management and leading quality and engineering functional teams and cross discipline project teams. Core competencies include: Cross Functional Team Leadership Organizational Development Staff Coaching Medical Devices and Combination Product Quality Systems Development and Deployment Strategic and Tactical Quality Planning Design Control Safety Risk Management Field Action Determination and Implementation Human Usability System Interoperability Lean and Agile Principles Quality and Reliability Metrics and Improvement CAPA and Nonconformance Management Post Market Surveillance Cybersecurity and Privacy Software Quality Master Validation Planning Production and Process Control Service Quality Change Management Electronic Document Management Systems Resource Allocation Global Regulatory Compliance Internal Quality Systems Auditing Supplier Management Regulatory and Customer Audit Management Electronic Learning Management Systems