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Meet the Team
Dedication. Expertise. Passion.

Arlyn Engebretson
Principal Quality Systems/Quality Engineering Consultant

Arlyn has over 25 years experience in the medical device industry and over 15 years experience as a BSI Certified Lead Auditor with knowledge of 21 CFR Part 11, 803, 806, &820 (FDA Quality Systems Regulations (QSR)), ISO 13485:2016, EUMDR & MDSAP. 

 

Arlyn created AME Quality & Compliance Solutions, LLC.  after 18 years of working and consulting for a variety of medical device and biotech companies. She is a firm believer that access to superior Quality Assurance services should be available to all biotech and medical device companies, both big and small. She also champions for a healthy work-life balance and encourages her team to do the same. 

 

Arlyn works alongside her team in all aspects of the projects and actively participates in the contracted services.

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Meet the dedicated experts behind AME Quality & Compliance Solutions, LLC.,

a highly skilled team passionate about helping our clients achieve their goals. 

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