Rosellen Miller
Sr Director, Quality Operations @Terumo Cardiovascular
Dayton, OH, US
EMAILS
MOBILE NUMBERS
+91 *********19
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WORK HISTORY
Jul 2024 — Present
Sr Director, Quality Operations @Terumo Cardiovascular
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Ann Arbor, MD
EDUCATION
2002 — 2007
The University of Toledo
Bachelors, Bioengineering
SKILLS
FmeaCqa21 CfrPart 820Fda GmpRisk ManagementVerification and Validation (V&V)Biomedical EngineeringManufacturingValidationMedical Device DirectiveCathetersMicrosoft OfficeMedical DevicesCapaQuality SystemV&VCross-Functional Team LeadershipIso 14971Project ManagementFailure Mode and Effects Analysis (Fmea)MinitabFdaCqeBiotechnologyRoot Cause AnalysisQuality AssuranceIso 13485Product LaunchDesign ControlAsq MemberCertified Quality Engineer (Cqe)GmpInjection Molding
ABOUT ROSELLEN MILLER
Experienced in product development, quality assurance and quality systems in a highly regulated industry. ASQ Certified Manager Quality/Operational Excellence (CMQ/OE)ISO 13485:2016 Lead Auditor (TPECS)ASQ Certified Biomedical Auditor (CBA)ASQ Certified Quality Engineer (CQE)ASQ Certified Quality Auditor (CQA)
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