Gary Utrup, Cmq-Oe Email & Phone Number

Southlake, Texas, Us

Austin, Texas, Us

Provided strategic / tactical direction, guidance and support to the Amcor Rigid Plastics USA, LLC Diversified Products organization, sites and customers building a business environment and quality management system compliant with ISO 9001, ISO 13485 and FDA quality management system requirements. Under my direction several sites have obtained ISO 9001 and ISO 13485 certifications: Amcor - Ft. Worth,TX, Amcor - Millville, NJ, Amcor - Youngsville, NC, Amcor - Blythewood, SC and Amcor - Itasca, IL

Draper, Utah, Us

AXEON is a firm that specializes in assisting quality-driven organizations to realize their full vision in achieving their Quality and Profitability objectives. Conducting gap analysis’s that highlights where serious “gaps” or “holes” are in a Quality/Business System, comparing actual work practices to an international standard such as ISO 9001:2008, AS9100, ISO 13485, U.S. FDA Qs Regulations or any other desired requirements document.

Developing a Quality Management System (QMS) for Medical Device manufacturers in the Asia-Pac Area. Responsible for providing leadership, guidance and training for the manufacturer's QMS implementation; developing quality system processes; drafting multi-level procedures and performing training on areas such as Complaint Handling, Document Control, CAPA, Adverse Event Reporting and Biosafety.Responsible for: - Developing and facilitating training of clients on FDA regulations, ISO standards and the Performance Excellence criteria. - Development and deployment of Quality Management Systems to meet FDA and ISO expectations. - Conducting and facilitating ISO Assessments and Compliance Audits

Providing strategic and tactical leadership, guidance and onsite support to a new business venture in the esoteric diagnostic laboratory healthcare environment defining, building, deploying measuring, analyzing (analytics) and training of the Quality Management Systems. The Organization achieved College of American Pathology (CAP) certification with ZERO findings. Defined, developed and deployedan FDA 21CFR, Part 11 compliant document and process control system for use in a CAP laboratory environment. Developed and deployed an Opportunity for Improvement (Complaints/NC/CAPA) process, an Adverse Event Reporting, Training, Document Control/Records, Executive Management Review, and Analysis of Data processes and systems engineering, building a profitable business environment compliant with CAP, ISO and CLIA Quality System requirements.

Abbott Park, Illinois, Us

Provided strategic and tactical guidance and support to the Global Service organization building a business environment compliant with ISO and FDA quality system requirements.

Abbott Park, Illinois, Us

Managed the Dallas, Diagnostic Division’s ISO/EN/GMP Compliance function including training strategies, budgeting, internal audits, FDA and other external audit facilitation, recalls, projects, and process improvement across multiple instrument programs. Prepared and Managed all ADD-Dallas ISO, [9001 & 13485], TickIT & EN Inspection activities, all communications between ISO/EN registrar and Dallas: surveillance assessments and Recertification inspection preparations, logistics and management updates.

Abbott Park, Illinois, Us

Managed the Site’s Regulatory and Compliance departments including Quality systems and ISO training strategies, budgeting, internal audits, FDA and other external audit/assessment facilitation, product corrections and recalls, projects, and process improvement across multiple instrument programs.

Abbott Park, Illinois, Us

Managed the technical service organization providing technical phone support and training to customers 24/7, over a broad range of innovative systems and tests for hospitals, labs and clinics, including the COMMANDER® immunoassay analyzers, the ABBOTT PRISM® fully automated blood screening system and the ADVANTAGE® MICROBIOLOGY platform. Responsible for registration, first-line resolution and escalation of customer complaints; identification and reporting of potential medical events; customer training content / delivery and field service dispatch.

Viral testing of all blood donations, problems solving , shift leadership and training of staff.

Bachelors, Biology

Asq Certification Cmq/Oe, Master In Quality Program

Bb(Ascp), Immunohematology For Medical Technologist, Sbb Masters Program