Barista / Sales

Noah Hoang

Bakersfield, CA 714-***-**** *************@*****.***

Professional Summary

Quality and regulatory operations professional with 2+ years of experience supporting FDA-regulated medical device environments. Proven expertise in complaint handling, MDR reporting, cross-functional collaboration, and maintaining audit-ready documentation. Known for accuracy, process discipline, and the ability to manage high-volume casework while meeting strict compliance standards.

Core Skills

• FDA MDR Reporting (21 CFR Part 803) • Medical Device Complaint Handling

• Quality Systems & Regulatory Documentation • Cross-Functional Collaboration (QA, RA, Engineering)

• Clinical & Customer Stakeholder Communication • Case Management & Trend Analysis

• Microsoft Excel, Word, PowerPoint • Process Improvement & Audit Readiness Professional Experience

Complaint Specialist I (Contract) — Edwards Lifesciences Irvine, CA Oct 2023 – Apr 2025

• Processed and resolved 40+ complaint investigations monthly by analyzing product performance, reviewing clinical data, and evaluating compliance with IFU and labeling requirements

• Partnered with Quality Assurance, Regulatory Affairs, and Product Development teams to investigate root causes, implement corrective actions, and reduce complaint recurrence rates

• Independently prepared and submitted 15+ MDR reports monthly to the FDA within regulatory timelines while maintaining 100% accuracy in documentation and record-keeping

• Identified and escalated critical safety trends through data analysis, leading to proactive risk mitigation strategies and enhanced patient safety protocols

• Supported product return investigations by coordinating with Engineering team and delivering comprehensive ad hoc quality reports that informed product improvement decisions Teacher / Lead Engineer — Engineering For Kids Of Kern Bakersfield, CA Jun 2023 – Oct 2023

• Designed end-to-end instructional curriculum for classroom environment focused on engineering concepts and hands-on projects

Property Manager — MV & Associates Real Estate

Bakersfield, CA Sep 2022 – Feb 2023

• Managed commercial and residential properties ensuring tenant satisfaction and timely rent collection while overseeing property maintenance and coordinating repairs

• Handled lease agreements, tenant screenings, and move-in/move-out processes while assisting in budgeting and financial reporting

Education

Bachelor of Arts in Criminal Justice

California State University, Bakersfield Aug 2020 – May 2022 Full Stack Development Certificate

University of California, Berkeley Mar 2023 – Jun 2023

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