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Noah Hoang

Noah Hoang

Quality and regulatory operations professional

Talent
Irvine, CAMember since June 17, 2026
FDA MDR Reporting (21 CFR Part 803)Medical Device Complaint HandlingQuality Systems & Regulatory DocumentationCross-Functional Collaboration (QA, RA, Engineering)Clinical & Customer Stakeholder CommunicationCase Management & Trend AnalysisMicrosoft ExcelMicrosoft Word
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FDA MDR Reporting (21 CFR Part 803)Medical Device Complaint HandlingQuality Systems & Regulatory DocumentationCross-Functional Collaboration (QA, RA, Engineering)Clinical & Customer Stakeholder Communication

About

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.

Experience

Complaint Specialist I (Contract) - Edwards Lifesciences - Irvine, CA

(2023-10 - 2025-04)

  • 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

(2023-06 - 2023-10)

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

Independent Landlord & Rental Property Owner - Independent - Southern California

(2018-01)

  • Managed a portfolio of residential and commercial rental properties over a 5-year period, overseeing all aspects of property operations including tenant acquisition, lease negotiation, and rent collection
  • Maintained high occupancy rates through proactive tenant communication, timely maintenance coordination, and thorough move-in/move-out inspections
  • Handled lease drafting, tenant screening, and compliance with local landlord-tenant regulations, ensuring legally sound and professionally managed tenancies
  • Administered financial reporting, budgeting, and expense tracking for rental income and property maintenance costs

Property Manager - MV & Associates Real Estate - Bakersfield, CA

(2022-09 - 2023-02)

  • 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 - Criminal Justice - California State University, Bakersfield (2020-08 - 2022-05)

Certificate - Full Stack Development - University of California, Berkeley (2023-03 - 2023-06)

Skills

Quality and regulatory operations professional

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