# Rolan Liong > Staff Software Quality Assurance Engineer Location: Saratoga, California, United States Profile: https://flows.cv/rolan Thesis Research was conducted to observe bacterial growth on the surface of metals in a static bioreactor. Metal and non- metal samples were subjected to bacterial exposures (1 day and 9 days). The metal samples were surface treated prior to bacterial exposure. The microstructures of the surface treated samples were analyzed by optical microscope. After exposure, the microstructures of the samples were analyzed by scanning electron microscopy (SEM). ## Work Experience ### Staff Software Design Quality Assurance Engineer Lead (equivalent to a manager role) @ Noah Medical Jan 2024 – Present ### Sr Design Quality Assurance (Principle equivalent) @ Avail Medsystems Jan 2022 – Jan 2023 | Santa Clara County, California, United States ### Sr. Software Design Quality Assurance Engineer @ Roche Jan 2020 – Jan 2022 ### Sr. Software Quality Assurance Engineer @ Proteus Digital Health, Inc Jan 2018 – Jan 2020 ### On Market Quality Assurance Engineer II @ Johnson & Johnson Vision Care, Inc. (Previously Abbott Laboratories ) Jan 2017 – Jan 2018 • Reduce change control volume by ensuring manufacture change orders’ technical content correctness and complying with company’s regulation. • Work closely with R&D and Manufacture engineers to understand the intent of the change orders (CAD drawings, BOM, schematics, GDP, design verification protocols, service bulletins, risk assessment) and assist in meeting company’s regulations. • Review CAD drawing and design verification protocols to ensure that all necessary changes are made in CAD drawing and proper GDP are documented in design verification protocols. • Bring up issues arises during evaluation of change orders process that causes confusion during calibration meetings to align document control team and quality engineers. • Advising engineers to consider checking other parameters, if the CAPA resolution stated in the change order is causing other issues while addressing the evaluation report. • Attend daily floor meeting with Manufacture engineers to take care of urgent change orders that affects the production lines (stock purge) to ensure the production lines run smoothly. • Evaluated and approved change orders in Agile. ### NPI Software Quality Engineer II @ Abbott Laboratories Jan 2016 – Jan 2017 • Review/maintain procedures to ensure design specification. • Modifying protocols with (R&D) team to control the design process. • Reviewed verification and validation (V&V) dry runs to ensure that the design meets the specified requirements. • Solid understanding of 21 CFR 820.30 and ISO 13845 requirements. • Supported Design Failure Mode and Effects Analysis (dFMEA), Risk management (RM), New product introduction (NPI), and Change order (CO) and Manufacturing change order (MCO) activities. • General understanding of database concepts, architecture, and design. ### Clinical Manufacturing Associate @ BioMarin Pharmaceutical Inc. Jan 2015 – Jan 2016 • Hands on experience with manufacturing of pharmaceuticals • Maintain GMP in clean room environment • Consulted on processing equipment evaluation • Modifying procedures with cross functional team to implement changes to operations / manufacturing • Support continuous improvement actives to better human factors for operators • Investigated supplier defects, and resolved issue with suppliers. • Six Sigma training obtained. ### Quality Assurance Engineer @ LandingZone Jan 2014 – Jan 2015 • Modified existing design which increase the company’s revenue by 20% • Developed testing approaches, methods, and performed testing protocol • Assisted in documenting design changes. • Verified and validated product and client issues. • Standardized and developed procedures • Reported customer issues to management via presentations ### Product Surveillance Coordinator @ St. Jude Medical Jan 2013 – Jan 2013 • Enforced and monitored FDA Warning letters and FDA Form 483. • Reviewed Medical Device Reports (MDRs) to submit to the FDA MAUDE database. • Monitored product complaints for resolution, including customer returned product. • Communicated with nurses, doctors and SJM representatives defining issue. • Background in the automated ICD functions, automated pacemaker functions, leads and terminologies. • Collaborated with cross functional teams to ensure the MDRs case are properly reported ### Intern @ InfiniWing Jan 2012 – Jan 2013 • Modified shipping database • Assisted in preparing the shipments of landing zone docking stations • Provided customer support • Assisted in solving issues arise from interfacing company’s website to the shipping company ## Education ### Master of Science (MS) in Biomedical/Medical Engineering California Polytechnic State University-San Luis Obispo ### Bachelor of Science (BS) in Biomedical/Medical Engineering California Polytechnic State University-San Luis Obispo ### Monta Vista High School ## Contact & Social - LinkedIn: https://linkedin.com/in/rolan-liong-aa934956 --- Source: https://flows.cv/rolan JSON Resume: https://flows.cv/rolan/resume.json Last updated: 2026-04-01