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Quality Systems Management

Abigail Davis possesses over 20 years in the industry including experience ranging from large, publicly- traded, highly-regulated companies to small, privately-owned, less-regulated companies. After graduating from University of Wisconsin – Madison in the 1990s, Davis worked in small contract labs conducting food testing and sterility testing on consumer products and medical devices. After those experiences, she joined Abbott Laboratories in northern Illinois. During her time at Abbott, Davis worked in multiple divisions, including the Diagnostics and Molecular divisions and she also worked in Corporate Quality and Regulatory. During her time with Abbott, she worked in a number of different functions and performed a large array of activities including manufacturing IVD products, QC testing products, qualifying manufacturing equipment. She also executed process validations, conducted internal and supplier audits, and hosted FDA inspections. Daivs currently works at Promega Corporation as a senior manager overseeing the quality system. She holds a master’s degree in Biotechnology from the University of Wisconsin – Madison.

Jeffrey Sartain

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Currently teaching:
Practical Quality Management

Jeffrey Sartain is a senior consultant providing quality system, regulatory compliance and general business subject matter expertise and project management services to health care product manufacturers. He has more than 30 years of experience within the medical device, diagnostics, pharmaceutical and food sectors, encompassing roles in quality and regulatory, engineering, and manufacturing, including international regulations and standards. Sartain's areas of expertise include compliance, quality system development and remediation, GxP, supplier/3rd party contract manufacturing controls, CAPA, complaint handling, and product development/transfer. Sartain earned a master's degree in manufacturing engineering from Northwestern University and has earned prior certifications as Quality Manager (ASQ), Lead Auditor (Stat-A-Matrix), Quality Systems/GMP (AAMI), and in Quality Engineering (ASQ).

Ruby Upadhyaya

Ruby Upadhyaya

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Currently teaching:
Medical Device Regulations

Ruby (Sunita) Upadhyaya presently serves as the senior director of quality and regulatory compliance for North America at Arjo, overseeing post market surveillance, field quality, QMS & regulatory compliance for the region. At Arjo, Ruby is responsible for ensuring that products and solutions offered in the North American market are designed, manufactured & distributed to meet both the market needs and legal requirements. Her role covers multiple portfolios including patient handling, disinfection, diagnostics and prevention of pressure injuries and venous thromboembolism. In addition to healthcare, Upadhyaya has spent several years in electronic manufacturing, institutional research, and consulting organizations. Ruby has an MS in an allied field of industrial engineering (majoring in planning & forecasting) from DAVV University. She also has regulatory affairs certification in medical devices & pharmaceuticals from RAPS, PMP from PMI and has earned multiple ASQ certifications (CBA, CMQ/OE, CQA, CQE, CSSBB) thru the course of her professional career.

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