“I have had the pleasure of working with Heather for several years now in various capacities. We worked together through the channels of the ASQ Biomedical Division and in my experience, Heather is a valuable contributor to promoting quality within the industry. In addition to the volunteer activities, I audited Heather's company as part of a Notified Body registration process and Heather's attention to detail and her knowledge and understanding of the quality system and device requirements were top notch, one of the best audits I've done. When it comes to quality and regulatory, you'll find few better.”
About
Medical device regulatory and quality professional with 15+ years of experience focusing…
Experience
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Education
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Activities and Societies: Sigma Kappa
Licenses & Certifications
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RAC (EU)
RAPS, Regulatory Affairs Professionals Society
Issued -
Certified Medical Device Auditor (CMDA)
ASQ, American Society for Quality
IssuedCredential ID 496 -
RAC (US)
RAPS, Regulatory Affairs Professionals Society
Issued
Volunteer Experience
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Member Board of Directors
ASQ - World Headquarters
- 6 years
Served on the society’s Board of Directors for three consecutive terms representing technical communities. ASQ provides the global community with the expertise, tools, and solutions to help organizations and individuals improve the products, services, and experiences relied upon for our safety, health, and daily lives. ASQ’s mission is to increase the use and impact of quality in response to the diverse needs of the world.
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Voting Member
US TAG to ISO/TC 176, Quality management and quality assurance
- Present 14 years 8 months
Develops the US position on international standardization activities of ISO Technical Committee 176 on quality management and quality assurance. ISO/TC 176 is responsible for the ISO 9000 family of Quality Management System standards and related Technical Reports.
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Voting Member
US TAG to ISO/TC 210/WG 01, Application of Quality Systems to Medical Devices Working Group
- Present 14 years 8 months
Develops the US position on standards for a quality management system that can be used by an organization involved in stages of the life cycle of a medical device, including ISO 13485 standard.
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Voting Member
ASC Z1 Subcommittee on Quality Management
- Present 14 years 8 months
Consensus body to develop generic American National Standards (ANS) in the field of quality assurance and quality management; may adopt international standards as written, or adapt as needed, to develop standards applicable and acceptable to US stakeholders. Vice Chair/Secretary Jan 2018-Dec 2019.
Publications
Honors & Awards
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Letter of Recognition
US Technical Advisory Group to ISO/TC 176
Recognition for efforts and extraordinary contributions in the following areas:
- Continued support, contributions and expertise in supporting the US position on standards
- Attention to detail in reviewing standards to ensure that they are written appropriately and provide timely response
- Participation and support on the project team for the TAG 176 Operating Procedures revision
- Leadership in the project team for the development and release of the TAG 176 Members Guidance Manual -
Marvin Rosenbaum Distinguished Service Award
ASQ Biomedical Division
For long and distinguished service to ASQ and the Biomedical Division. Such service can include leadership positions on the Division Council as well as Society, but must also include other service of a continuing and long term nature. The recipient's work should be so outstanding as to have had a lasting and meaningful effect on the Division.
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Testimonial Award
ASQ
For continued, professional, dependable and tireless leadership of the ASQ Biomedical Division and the support and mentoring of her leadership team.
Organizations
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Partnerships for Children
Member Board of Directors
-Partnerships for Children provides critical resources to abused and neglected children in Central Texas who are in the care of Child Protective Services. Learn more about this non-profit organization at www.partnershipsforchildren.org.
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ASQ Biomedical Division
Chair
-The Biomedical Division of the American Society for Quality (ASQ) is a professional technical community focusing its awareness that Quality has a primary role in providing quality medical devices to patients and healthcare professionals. Through its numerous activities, the Division works toward being the leading authority of Quality issues related to the biomedical community.
Recommendations received
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