Timothy Bui
Revere,USA
Overview
6
6
years of professional experience
Work History
Complaint Handling Operations Investigator
Koninklijke Philips N.V / Philips
03.2020 - Current
- Manage investigation, coding, and resolution of 100+ global complaint cases per month for medical devices, ensuring 100% compliance with FDA, EU MDR, and other international regulatory requirements.
- Author and review over 200 post-market surveillance documents annually, including vigilance reports and non-reportability justifications, contributing to regulatory compliance and risk mitigation.
- Collaborate cross-functionally with 5+ departments such as Engineering, Medical Affairs, R&D, and Regulatory Affairs to align on reportability decisions, improving communication and reducing investigation turnaround time by 15%.
- Utilize TrackWise QMS and SAP to query and close complaint records; supported 3+ FDA and ISO audits with zero major findings through meticulous data trending and record management.
- Prepare and present daily complaint metrics and KPIs to a team of 10+ members using Excel dashboards, driving continuous process improvements and enhancing team productivity by 20%.
- Support CAPA processes by escalating and tracking complaint trends and non-conformances, contributing to a 30% reduction in repeat complaint cases through root cause analysis and corrective actions.
Front Desk Agent / Night Auditor
Boston Park Plaza
08.2019 - 03.2020
- Performed nightly audits for 1,060-room, 4-star hotel; managed fiscal closing for all shifts
- Resolved guest issues and coordinated front office functions to ensure service excellence and compliance with hotel policies
Education
Bachelor of Science - Public Health and Sciences
University of Massachusetts Amherst
Amherst, MA12.2018
Skills
- Quality Systems: TrackWise QMS, SAP, Azure DevOps, Salesforce, eDMR
- Software: Microsoft Office Suite (Excel, Word, Outlook, PowerPoint, Access)
- Regulatory: Knowledge of FDA 21 CFR 820, EU MDR, CAPA, FCO, STICR
- Reporting: Authoring and peer-review of regulatory vigilance reports (MAUDE, MIR)
Timeline
Complaint Handling Operations Investigator
Koninklijke Philips N.V / Philips
03.2020 - Current
Front Desk Agent / Night Auditor
Boston Park Plaza
08.2019 - 03.2020
Bachelor of Science - Public Health and Sciences
University of Massachusetts Amherst
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