RC

Robert Lawery, CQE CSQE

Director, Quality Assurance & Regulatory Affairs at Galen Robotics

Robert Lawery has a diverse work experience in the field of quality assurance and regulatory affairs. Robert is currently working as the Director of Quality Assurance & Regulatory Affairs at Galen Robotics since May 2020. Prior to this, Robert served as a Medical Device Quality Consultant for various companies from March 2013 to April 2020, where they successfully led a project to generate a response to an FDA Warning Letter, resulting in its closeout with no further tasks or follow-up inspections required. Robert also played a significant role in migrating Audit, NCR, and CAPA records from Agile to SmartSolve as a Quality Systems Consultant.

Previously, Robert worked as the Device Quality Manager for On-Market Serialized Devices and Software at Hospira from January 2011 to February 2013. Robert also held the position of Senior Manager of Quality Engineering - Renal Division at Baxter Healthcare from July 2008 to December 2010.

Earlier in their career, Robert gained expertise in software quality assurance and validation, serving as a Sr. Project Manager at Covidien from July 2005 to July 2008 and as a Sr. Software Validation Engineer at Covidien (formerly Tyco Healthcare) from July 2005 to July 2007. Robert also worked as the Manager of Software Quality Assurance at Nellcor/Puritan Bennett (Covidien) from January 2003 to June 2005.

Before joining the medical device industry, Robert worked as a Lead Sr. Software Quality Assurance Engineer at Therasense / Abbott Diabetes Care (Abbott Laboratories) from 2000 to 2002. Robert also held the same position at Therasense from 2000 to 2002.

Robert began their career as the Manager of Software Quality Assurance at Zeiss Humphrey Systems from 1999 to 2000.

Robert Lawery, CQE CSQE, has a strong educational background. Robert first attended Pratt Institute from 1985 to 1990, where they obtained a Bachelor of Electrical Engineering (BEE) degree with a focus on Electrical Engineering. Following this, they pursued further education at Keller Graduate School of Management of DeVry University, earning a Master of Business Administration (MBA) degree specializing in Marketing and Strategic Management. Robert'sstudies at Keller Graduate School took place from 1992 to 1995.

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  • Director, Quality Assurance & Regulatory Affairs

    May, 2020 - present