Joshua Thao
Senior Quality Engineer
Summary
Highly skilled and experienced Senior Quality Engineer with over 10 years of expertise in quality manufacturing and quality management systems. Proficient in ensuring compliance with industry standards, regulations, and best practices for 510K/PMA class II/III devices. Proven track record in driving continuous improvement initiatives, optimizing quality processes, and leading cross-functional teams to deliver exceptional results.
Overview
14
14
years of professional experience
Work History
Senior Quality Engineer
Inspire Medical
Golden Valley, Minnesota
11.2024 - Current
- Conducted root cause analysis on production issues related to non-conforming products.
- Collaborated with cross-functional teams to resolve quality-related issues efficiently.
- Reviewed and approved design documentation to ensure regulatory adherence.
- Reviewed manufacturing processes, technical documents and test results for accuracy and completeness.
- Evaluated customer feedback and complaints to identify areas of improvement in product quality.
Senior Quality Engineer
Urotronic
Plymouth, MN
07.2022 - 11.2024
- Collaborated with quality team members and leaders to monitor conformance to quality standards.
- Performed root cause analysis for detected faults and developed corrective actions.
- Drafted process documentation to standardize operating procedures and techniques.
- Facilitated improvement protocols to decrease error rate and mitigate non-conformance.
- Maintained ISO documents within manufacturing facilities to comply with applicable regulations.
Quality Engineering Supervisor
Tactile Medical
New Brighton, MN
06.2021 - 07.2022
- Facilitate monthly post-market surveillance and weekly material review board meetings
- Document, evaluate, disposition, and investigate product reports and identifying field complaints
- Provided spot troubleshooting of unexpected issues with products, manufacturing and design phases.
- Supervise and guide inspectors, technicians and other staff.
- Design and installed preventive maintenance programs to reduce work disruptions.
Quality Engineer
Tactile Medical
New Brighton, MN
11.2019 - 06.2021
- Perform product inspections and reported results detailing errors, failures and non-conformance.
- Contribute to root cause evaluation to mitigate risk and foster continuous improvement.
- Draft process documentation to standardize operating procedures and techniques.
- Reviewed lot history to assess process flow and to ensure correct subassembly components are utilized for production builds.
- Gathered and organized data to analyze current industry trends.
Product Development Engineer II
Pentair
White Bear Lake, MN
03.2016 - 11.2019
- Prepared and executed tests to support product development design verification in fountain systems for positive qualification results towards internal and external parties
- Supported continuous improvement efforts in mineral blend application for on demand water system to create optimal coffee beverages
- Compiled data and defined changes required in mineral cartridges to meet customer design and specifications on residential water filtration
- Engineered reliability and performance test stands on new and existing filtration products to analyze product quality performance
Product Development Engineer I
Pentair
White Bear Lake, MN
07.2012 - 03.2016
- Successfully designed, developed, and optimized 4" (0.02μ) ultra-filtration module for food service operations that have challenges with frequent water filter changes
- Oversaw production training and validation for ultra-filtration membrane among cross-functional team
- Constructed root cause analysis testing methods for return material authorization on short life filter membrane with complete and thorough failure analysis report
- Authored standard operating procedure for ultra-filtration membrane to ensure product and process maintain a high standard of quality
- Generate document change forms in the implementation on new or modification products within the management system
- Created IQ/PQ/OQ validation for air integrity test stand used to assess filtration efficiency
Education
Bachelor of Science - Biomedical Science
University of Wisconsin - River Falls
River Falls, WI12.2010
Master of Science - Applied Clinical Research
Saint Cloud State University
Saint Cloud, MN12.2021
Skills
- Non-conformance processes
- Corrective Action Preventive Action
- Failure Mode and Effects Analysis
- Post-Market Surveillance
- Medical Device Reporting
- ISO 9001/13485/14971
- 21 CFR Part 820/QMSR
- External/Internal Audits
- 510K/PMA
- Proficient with MS Word, Excel, and Power Point
Timeline
Senior Quality Engineer
Inspire Medical
11.2024 - Current
Senior Quality Engineer
Urotronic
07.2022 - 11.2024
Quality Engineering Supervisor
Tactile Medical
06.2021 - 07.2022
Quality Engineer
Tactile Medical
11.2019 - 06.2021
Product Development Engineer II
Pentair
03.2016 - 11.2019
Product Development Engineer I
Pentair
07.2012 - 03.2016
Master of Science - Applied Clinical Research
Saint Cloud State University
Bachelor of Science - Biomedical Science
University of Wisconsin - River Falls