skip to Main Content
Our People

The RookQS team leverages its extensive experience and expertise in quality and regulatory strategies for emerging and established medical device companies to help our clients get their devices to market significantly faster than standard methods.

Our consultants provide clients with the necessary tools to comply with regulations in both domestic and international markets, with specialists in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity. Our diverse team works with a wide range of devices (including class I-III devices, SaMD, and IVDs).

RookQS’ team of experienced, certified Quality Engineers features 11 certified quality auditors (CQAs) for a variety of regulations, including FDA 21 CFR 820, ISO 13485:2016, MDSAP, and CE Mark under MDR.

Our Leadership
Founder/President

Kyle is a Medical Device expert specializing in the development of efficient Quality Systems for small and startup medical device companies. Kyle founded Rook Quality Systems in 2012 to enable clients to implement compliant Quality Management Systems (QMSs), and to ensure that clients can efficiently produce effective and reliable medical devices. Rook has been overseeing overall quality strategy and ensuring compliance through documentation and auditing services for nearly a decade.

Kyle is a certified quality auditor (CQA) and has regulatory and submission experience for a variety of markets including FDA, CE Mark, Health Canada, and CFDA. Kyle encourages the simplification of Quality Systems to reduce the quality burden and improve compliance through training and efficient QS design.

General Manager, Taiwan Branch

Andrew is a medical device innovation fellow who joined Rook Quality Systems in 2016 as a Software Quality Assurance Consultant, managing verification & validation testing and strategy on various medical device embedded software to ensure conformance to FDA software validation guidance and IEC 62304.

In 2020, Andrew was elevated to the position of General Manager of Rook’s Taiwan branch, where he led the launch of Rook’s first international branch office. Andrew oversees a team of five software quality engineers focused on helping clients in the Asia-Pacific region and around the globe with technical development, quality and regulatory strategy in the software as medical device space.

Our Team

Grace Cupp
Software Quality Engineer

Chandler Thames
Quality Manager

Sarah Lacey Robbins
Quality Manager

Sarah Nixon
Quality Engineer

Aditi Pillai
Quality Engineer

Austin Olvera
Quality Engineer

Michael Chen
Quality Engineer

Jill Chen
Regulatory Affairs Manager

Ricky Lee
Quality Engineer

Bobby Cork
Quality Engineer

Jakemia Barnette
Quality Engineer | Project Manager

Molly Lane
Quality Engineer

Allen Chen
Software Quality Engineer | Project Manager

Meredith Haller
Quality Engineer | Regulatory Affairs Strategy

Monoj (Mon) Kalita
Associate Regulatory Affairs Manager

Roland Shum
Software Engineer

Kevin Chambliss
Quality Engineer (Contractor)

Philip Andrews
Senior Auditor (Contractor)

Reni Ajoy
Software Quality Engineer

Patrick Sherman
Head of Growth

Corinth Chandler
Office Manager

Arya Monticino
Quality Engineer

Ally Reichart
Quality Engineer

Samantha Hoffman
Quality Engineer

Lee Brewer
Quality Engineer

Subscribe to our Newsletter
Join our mailing list for the latest Rook events, thought leadership, and more.
Back To Top