Brie Stoianoff
Vice President, Quality Assurance and Regulatory Affairs @Hemex Health, Inc
Portland, OR, US
EMAILS
MOBILE NUMBERS
+91 *********19
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WORK HISTORY
Sep 2024 — Present
Vice President, Quality Assurance and Regulatory Affairs @Hemex Health, Inc
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Portland, OR, US
Driving market access strategy and quality management system compliance to deliver innovative diagnostic solutions to the frontlines of healthcare.
EDUCATION
N/A
King's College London
Study Abroad
N/A
Temple University School of Pharmacy
M.S.
N/A
The College of Idaho
B.S. with Honors, Gipson Scholar
SKILLS
FdaGmpRegulatory AffairsQuality SystemsCapaDesign ControlTrainingQuality SystemCross-Functional Team LeadershipManufacturingSop21 Cfr Part 1121 CfrMedical DevicesAuditingIso 13485Process ImprovementQuality AuditingR&DLean ManufacturingSoftware DocumentationQuality AssuranceValidationQuality ControlRegulatory RequirementsQuality ManagementPharmaceutical IndustryIsoContinuous ImprovementRoot Cause AnalysisV&VIso 14971Regulatory SubmissionsChange ControlCe MarkingFda GmpComputer System ValidationComplaint ManagementDmaicFmea
ABOUT BRIE STOIANOFF
Brie Stoianoff is a MedTech Quality and Compliance expert with over 20 years of…
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