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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 13 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


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
Director of Quality

Sarah Lacey Robbins
Quality Manager

Aditi Pillai
Senior Quality Engineer

Michael Chen
Quality Engineer

Jill Chen
Senior Regulatory Affairs Specialist

Ricky Lee
Quality Engineer

Karly Ripple
Quality Engineer

Benjamin Jones
Business Intelligence Associate

Jaclyn Maney
Marketing Specialist

Ramsha Navaid
Quality Engineer

Bobby Cork
Director of Business Development

Jakemia Barnette
Quality Engineer | Project Manager

Molly Layne
Quality Manager

Allen Chen
Software Quality Engineer | Project Manager

Meredith Pyne
Quality Engineer | Regulatory Affairs Strategy

Deepika Pothiraju
Regulatory Affairs Specialist (IVDR & MDR)

Stephen Chan
Quality Engineer | Regulatory Associate

Kevin Chambliss
Senior Quality Engineer

Terence Chang
Quality Engineer

Philip Andrews
Senior Auditor

Reni Ajoy
Software Quality Engineer

Patrick Sherman
Head of Growth

Corinth Chandler
Office Manager

Ally Reichart
Quality Engineer

Samantha Hoffman
Quality Engineer

Lee Brewer
Quality Engineer

Ray Losch
Quality Manager

Andy Su
Senior Regulatory Affairs Specialist

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