Gary Utrup, CMQ-OE
Kennedy Western University
Tell me more about Gary Utrup, CMQ-OE?
Gary Utrup, CMQ-OE, is an accomplished and certified leader with 45.9 years of experience in quality assurance and regulatory compliance. He has a comprehensive background in process management, supplier development, and regulatory compliance. Gary has extensive multi-industry experience in R&D, operations, customer support, technical service, field service, laboratory operations, manufacturing, and supplier development processes. He is skilled in training and staff development, strategic planning, and training and development. Gary is known for his strong interpersonal and problem-solving skills, as well as his ability to develop strategic and tactical initiatives. He has worked in various industries, including R&D, operations, customer support, technical service, field service, manufacturing, and supplier development.
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About
Accomplished, certified (CMQ/OE), and acknowledged goal-oriented leader with a comprehensive background in process management, supplier development, adverse event reporting, regulatory compliance; regulatory/ISO audits/assessments preparation, and facilitation for various quality management systems. Extensive multi-industry experience within R&D, Operations, Customer Support, Technical Service, Field Service, Laboratory Operations, Manufacturing and Supplier Development processes, and functions. Utilizing strong innovative leadership and management skills; along with proven expertise in training and staff development and strategic planning to enhance the overall business profile. Experienced in Quality Management Systems development, deployment, remediation, auditing and assessing against FDA 21CFR, 211, 820, ISO13485, ISO 9001, AS9100, CLIA/CAP, Food Safety, MBNQP and AS requirements using excellent interpersonal skills, with proficiency in cultivating professional relationships and implementing best practices to develop highly effective business programs.Developing simple, systematic and sustainable systems, processes and training programs that ensure the alignment of the overall strategy of the organization with its business objectives and the local community.A dedicated, results-oriented team player with strong interpersonal, communication, analytical and problem-solving skills experienced in the development and deployment of strategic and tactical initiatives that cultivate positive relationships and strategic alliancesSpecialties: Quality Management Systems Regulatory Compliance Customer Satisfaction Process development/improvement Complaint Handling Management Change Strategic planning/analysis Project/process management Risk Management / HACCP QMS Development & Remediation Team Leadership Training & Skill Development EDGE process utilization Auditing & Assessment IFS PacSecure/Food Safety
...See MoreWork Experience
quality manager at heartsciences
Quality Manager
Medical Equipment Manufacturing
Gary Utrup, CMQ-OE's Professional Milestones
- Supervisor, Diagnostic Products And Mircobiology Reagents And Instrument Systems Customer Support Center (1987-01-01~1993-01-01): Implemented effective strategies for diagnostic products and Mircobiology reagents and instrument systems, ensuring exceptional customer support.
- Quality Assurance / Regulatory Compliance / Oe Consultant (2014-08-01~2015-05-01): Improving compliance measures and implementing effective processes to streamline processes and enhance customer satisfaction.
Education
Masters,
Master In Quality Program
2003-2006Skill
Quality Assurance
Quality System
Fda
Cross Functional Team Leadership
Medical Devices
Capa
Process Improvement
Quality Auditing
Leadership
Management
Iso 13485
Continuous Improvement
Training
Program Management
Quality Management
Validation
Testing
Sop
Project Management
Gmp
Immunoassays
Regulatory Affairs
Six Sigma
Process Engineering
21 Cfr Part 11
Iso
Manufacturing
System Deployment
Laboratory
Biotechnology
Strategy
Recalls
Change Control
V&v
Design Control
Team Leadership
Pharmaceutical Industry
Iso 9000
Leadership Development
Strategic Planning
Quality Control
Coaching
Glp
Hardware Diagnostics
Microbiology
Lifesciences
Clinical Trials
Sdlc
Quality Systems
Compliance Audits
Certification
Colleagues
Mark Hilz
Chief Operating Officer
Andrew Simpson
Chairman & CEO, HeartSciences (Nasdaq: HSCS)
Danielle Watson, CPA
chief financial officer at heartsciences
Carol Krieger
vp clinical & regulatory at heartsciences
Paul Klotz
Senior Vice President Of Operations
Other Named Gary Utrup, CMQ-OE
Frequently asked questions
We found 3 Gary Utrup, CMQ-OE's email addresses
We found 2 Gary Utrup, CMQ-OE's phone numbers
Gary Utrup, CMQ-OE's social media include: Linkedin,
Gary Utrup, CMQ-OE works for HeartSciences (NASDAQ:HSCS)
Gary Utrup, CMQ-OE's role in HeartSciences (NASDAQ:HSCS) is quality manager at heartsciences
Gary Utrup, CMQ-OE works in the industry of Medical Equipment Manufacturing
Gary Utrup, CMQ-OE's colleagues are Mark Hilz,Andrew Simpson,Danielle Watson, CPA
Gary Utrup, CMQ-OE's latest job experience is quality manager at heartsciences at HeartSciences (NASDAQ:HSCS)
Gary Utrup, CMQ-OE's latest education in Kennedy Western University