
Michelle Engelhardt
As a Senior Quality and Change Management Leader, I have 20+ years of experience in regulatory compliance and... | 3312 Corral Creek Drive, Mckinney, United States
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Michelle Engelhardt’s Emails mi****@gr****.com
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Michelle Engelhardt’s Location 3312 Corral Creek Drive, Mckinney, United States
Michelle Engelhardt’s Expertise As a Senior Quality and Change Management Leader, I have 20+ years of experience in regulatory compliance and quality assurance. I have a proven background in developing strategic quality initiatives, optimizing organizational processes, and leading dynamic teams. It is my passion to achieve industry-leading performance and compliance across healthcare and bio-pharmaceutical sectors. Key Achievements Include: ✅ Evolved and transformed into an impactful, people-centric leader who builds and directs high-performing teams, manages multimillion-dollar budgets, and drives substantial performance improvements ✅ Recognized for managing quality for hundreds of plasma centers and corporate systems collectively, including managing 660 staff and a 16M budget across 6 cost centers, ensuring compliance, validation, change control, auditing, analytics, and risk management ✅ Designed and rolled out Quality Metrics Dashboard within 3 months, monitoring 16 metrics and improving performance 50%, and implemented a donor management system that automated 95% of processes and nearly eliminated paper usage ✅ As Head of Quality, pioneered quality assurance for Grifols’ Southwest Division, overseeing 33 blood plasma sites with a 217M budget, reducing error rates below company average for 7 quarters, maintaining a voluntary turnover rate under 30% for 2 years, and decreasing deviations from over 200 to 30 or less per center through strategic planning and strong team development Contact me through this profile if you wish to connect.
Michelle Engelhardt’s Current Industry Grifols
Michelle
Engelhardt’s Prior Industry
Baylor Scott And White Health
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Grifols
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Work Experience

Grifols
Director, Corporate Quality Assurance
Sun Jul 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Grifols
Head of Quality
Fri Feb 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jun 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Grifols
Regional Quality Manager
Tue Aug 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Feb 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time)
Baylor Scott And White Health
Medical Technologist
Tue Oct 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Aug 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time)