Thoai Tran
@thoaitran
Senior Quality Assurance Engineer improving ISO/FDA quality systems across medical device and aerospace supply chains.
United StatesWhat I'm looking for
I support supplier quality programs and corrective actions across FDA- and ISO-regulated manufacturing, including work on shipment quality and supplier performance.
At Cytovale and Lucira Health (by Pfizer), I managed audits, SCARs, CAPAs, calibration and preventive maintenance, and QMS documentation updates to keep ISO 13485/AS9100 and FDA 21 CFR Part 820 compliance moving.
I’ve also led Quality through ERP and eQMS initiatives—designing GMP-compliant workflows, validating processes, and preparing teams for adoption—while keeping audit readiness and internal audit closure on track.
Experience
Work history, roles, and key accomplishments
Directly support $65 million worth of shipment by managing supplier quality programs. Lead NCR, SCAR, and corrective action activities, partnering with suppliers to resolve manufacturing issues and improve quality performance across the supply network.
Managed supplier audits, SCARs, CAPAs, and supplier performance to ensure compliance with ISO 13485, AS9100, and FDA 21 CFR Part 820. Partnered with suppliers and cross-functional teams to resolve quality issues and drive corrective actions.
Managed 200+ equipment assets, maintaining calibration schedules and preventive maintenance programs to ensure GMP compliance. Improved QMS documentation by updating SOPs and work instructions, supporting regulatory readiness and operational consistency.
Quality Engineer
Lucira Health (by Pfizer)
Mar 2022 - May 2022 (2 months)
Supported ISO 13485 certification readiness, enabling expansion of product distribution into global markets. Strengthened regulatory compliance by leading internal audits and QMS improvement initiatives.
Quality Engineer Technician
Lucira Health (by Pfizer)
Aug 2021 - Mar 2022 (7 months)
Led a team of QE technicians responsible for lot release quality operations. Managed calibration and maintenance programs for 1300+ equipment assets across multiple facilities.
Assembled robotic surgical system components following precision manufacturing procedures and quality standards. Maintained multiple assembly workstations performing mechanical and electrical subassembly builds.
Education
Degrees, certifications, and relevant coursework
Merritt College
Associate of Science, Cyber Security Infrastructure
Associate of Science in Cyber Security Infrastructure from Merritt College, completed in June 2024.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
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