Michelle Engle
Director of Quality Assurance and Regulatory Affairs at Medical Murray | Flower Mound, Texas, United States
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As the Director of Quality Assurance and Regulatory Affairs at Medical Murray, Michelle Engle plays a pivotal role in ensuring that the company not only meets but exceeds the stringent standards set forth by regulatory bodies in the medical device industry. With a robust background in quality management systems and regulatory compliance, Michelle is instrumental in defining and leading the company's regulatory and quality strategies. Her expertise encompasses a wide range of critical areas, including contract research and development, FDA registration activities, and the implementation of ISO 13485:2016 standards.
One of Michelle's key projects involves the continuous enhancement of Medical Murray's Quality Management System (QMS), ensuring that it remains compliant with both regulatory requirements and customer expectations. She actively oversees audits, both internal and external, to identify opportunities for improvement and ensure adherence to best practices. Her leadership in Corrective and Preventive Action (CAPA) processes is essential for mitigating risks and fostering a culture of quality throughout the organization.
Michelle's strong interpersonal skills and customer service orientation enable her to effectively communicate complex regulatory requirements to diverse stakeholders, fostering collaboration and trust. Her proficiency in protocol writing and statistical analysis further enhances her ability to lead teams in developing innovative solutions that align with industry standards. As Medical Murray continues to expand its capabilities in contract manufacturing and design, Michelle Engle remains a cornerstone of the company’s commitment to delivering high-quality medical devices that improve patient outcomes.
Director of Quality Assurance and Regulatory Affairs at Medical Murray in November 2022 to Present
Quality Assurance and Regulatory Affairs Manager at Medical Murray in January 2021 to November 2022
Quality Manager at Medical Murray in December 2017 to January 2021
Quality Engineer at Medical Murray in May 2015 to December 2017
Undergraduate Research Assistant at Klesney-Tait Laboratory in April 2013 to May 2015
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Regulatory Compliance
Certified Lead Auditor
Teamwork
Biomedical Engineering
Leadership
Statistics
Validation
Data Analysis
Medical Devices
Report Writing
Internal Audit
Calibration
ISO 13485
Six Sigma
Problem Solving
Time Management
Customer Service
Employee Training
Team Leadership
Protocol Writing
21 Cfr
Part 820
Contract Manufacturing
Corrective and Preventive Action (CAPA)
Continuous Improvement
ASQ
Kaizen
Quality Management
Quality System
Quality Auditing
Interpersonal Skills
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Discover more about Medical MurrayWhat is Michelle Engle email address?
Email Michelle Engle at [email protected]. This email is the most updated Michelle Engle email found in 2026.
What is Michelle Engle phone number?
Michelle Engle phone number is +18474093412.
How to contact Michelle Engle?
To contact Michelle Engle send an email to [email protected]. If you want to call Michelle Engle try calling on +18474093412.
What company does Michelle Engle work for?
Michelle Engle works for Medical Murray
What is Michelle Engle's role at Medical Murray?
Michelle Engle is Director of Quality Assurance and Regulatory Affairs
What industry does Michelle Engle work in?
Michelle Engle works in the Medical Equipment Manufacturing industry.
Michelle Engle Email Addresses
Michelle Engle Phone Numbers
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