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Beth Kelly

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Beth Kelly

New England Medical Device Board Member, Past Chair, Past Chair Elect | ASQ - World Headquarters

Concord, Massachusetts, United States

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Beth Kelly

Summary

Beth Kelly is an accomplished Principal Consultant specializing in quality and compliance within the medical device sector. With extensive expertise in regulatory affairs, she navigates complex standards such as 21 CFR 820 and ISO 13485, ensuring organizations meet stringent compliance requirements. Beth is a certified quality auditor and a recognized leader in the field, having conducted FDA certification audits and provided training on readiness and remediation. Her passion for quality is matched by her commitment to mentorship, actively volunteering with the ASQ Medical Device Division. In addition to her professional accomplishments, she holds US and European patents, showcasing her innovative contributions to the industry. Beth's background in biomedical engineering and her role in cross-functional leadership make her a valuable asset in any compliance-related initiative. Her strategic approach to quality management and process improvement drives operational excellence in the organizations she collaborates with.

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Beth Kelly

Work Experience

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New England Medical Device Board Member, Past Chair, Past Chair Elect at

ASQ - World Headquarters

January 2006 - Present

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Principal Consultant at

Kelly Quality And Compliance

January 2004 - Present

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ASQ Biomedical Division Program Chair at

American Society for Quality

January 2010 - December 2018

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Site Management Representative at

Abbott Co

January 2002 - January 2003

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Beth Kelly

Education

Frequently Asked Questions about Beth Kelly

What company does Beth Kelly work for?

Beth Kelly is a New England Medical Device Board Member, Past Chair, Past Chair Elect at ASQ - World Headquarters, a company specializing in Business, Professional, Labor, Political, & Similar Organizations .

Where Beth Kelly graduated from?

Beth Kelly holds a degree in Biology, General from University of Oregon.

Who is Beth Kelly?

Beth Kelly is an accomplished Principal Consultant specializing in quality and compliance within the medical device sector. With extensive expertise in regulatory affairs, she navigates complex standards such as 21 CFR 820 and ISO 13485, ensuring organizations meet stringent compliance requirements. Beth is a certified quality auditor and a recognized leader in the field, having conducted FDA certification audits and provided training on readiness and remediation. Her passion for quality is matched by her commitment to mentorship, actively volunteering with the ASQ Medical Device Division. In addition to her professional accomplishments, she holds US and European patents, showcasing her innovative contributions to the industry. Beth's background in biomedical engineering and her role in cross-functional leadership make her a valuable asset in any compliance-related initiative. Her strategic approach to quality management and process improvement drives operational excellence in the organizations she collaborates with.

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Colleagues

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Kush Shah

Chairman - ASQ Automotive Division

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Mps Seiche Sanders

Publications Director, Editor in Chief and Publisher

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Art Rankis

Founder, President and Principal Consultant

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Paul Ranky

Former Executive Board Member, ASQ, American Soc. for Quality, New York, New Jersey Section

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David Leo

Chair - RAPS Boston Chapter

Jay Jayashankar

Board Member and Education Committee co-chair, MN ASQ

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