Key Personnel

 
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Mya Thomae, RAC, CQA
Founder and CEO

Mya has over 15 years of experience with regulatory and quality, much of it as a consultant.  Prior to becoming a consultant, Mya learned the ropes at Chiron and OraSure....

Consultants

Leonard Buchner
Senior Director

Leonard has more than 30 years of experience in the IVD industry, with a particular specialty in biostatistics and clinical trial design. Leonard has extensive experience building, directing and managing...

Jo-Ann Gonzales, RAC
Manager

Jo-Ann has over 12 years of regulatory experience, 10 of which have been specifically with IVDs. She comes to MyRAQA having served in regulatory for four years at Novartis and...

Lorry Huffman
Senior Director

Lorry has more than 20 years of experience managing regulatory affairs in both the device and pharma industries. Lorry has built and supervised RA/QA departments and led regulatory efforts in...

David Kern, MBA
Director

David has more than 15 years of experience developing IVD and life science products.  His experience in product development, project management, business development and relationship management grants him a wide...

Claudia Koontz
Clinical Research Associate

Claudia has a diverse array of experiences supervising projects, resources, communications and accounting functions in a variety of industries. Over 15+ years, Claudia has played key roles in clinical, telecommunications,...

Tina M. Landess, CCRA
Director

Tina has more than 16 years of experience in the biotechnology industry, nearly all of which has been with a focus on researching and developing products within the diagnostic field....

Maureen Mende, RAC, MBA
Senior Director

Maureen has over 25 years of experience in the regulatory and quality arenas, including 16 years specifically in IVD regulatory. She comes to MyRAQA from two years at Affymetrix, where...

Don Rackham
Manager

Don has over 15 years of experience in life sciences, including clinical diagnostics and pharmaceuticals. Don comes to MyRAQA from Affymetrix, where he was Quality Control Manager at their West...

Mark M. Sweeny, MA
Director

Mark Sweeny was a key player in the regulatory, quality and compliance function at Applied Biosystems from 1990 until he joined MyRAQA in 2008.  During his time at AB, Mark...

Cindy Van Duker
Manager

Cindy has more than 10 years of experience managing regulatory affairs for IVD and medical device products. She comes to MyRAQA from Volcano Corporation, where she served as Manager of...

Diane M. Ward, PhD
Senior Director

Diane Ward is an immunologist with over 20 years of experience in the diagnostic industy and has a comprehensive track record in new product development.  With particular expertise in systems...

Jack Ward, CQM, CSQE
Director

Jack Ward has more than 25 years of experience working with quality, compliance and R&D at a wide range of medical device companies. Jack spent more than 10 years in...

Operations

Bryan Hardester
Finance Manager

Bryan is an accomplished musician who became a top performer at his "day job" by bringing an artistic level of discipline and dedication to everything he does.  Bryan has managed...

Dave Moore
Operations Associate

Dave Moore comes to MyRAQA from Adobe Systems, where he was a Volume Licensing Manager. Dave has had management positions in software, marketing, retail and nonprofits. Although he is new...

Dylan Reinhardt
Director of Operations

Dylan comes to MyRAQA from a career in computer programming, IT management and corporate communications. In 2000, Dylan helped Mya set up her first web site and has been involved...

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