Anne Holland

Founder and CEO @Qa Consulting, Inc

Austin, TX, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jan 2000 — Present

Founder and CEO @Qa Consulting, Inc

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Austin, TX, US

More than 30 years of experience in Quality and Engineering leadership in the medical device industry. Experience with products ranging from wheelchairs to heart valves with many product types along the technology continuum.Founded QA Consulting, Inc. in the following certifications: CQE, CQA, CQM, RQAP-GLP, and RABQSA Lead AuditorSpecialties: FDA. EU MDR. Quality Systems, Risk Management, Litigation Support Design Control, Verification and Validation, Regulatory, Quality System Remediation, Design Controls, Sterilization, Second-Party Audits,

EDUCATION

1989 — 1991

University of Colorado Denver

MBA, Business, Management, Marketing, and Related Support Services

1980 — 1985

Vanderbilt University

B.S., Biomedical Engineering

SKILLS

Supplier QualityIso 14971Standard Operating Procedure (Sop)Regulatory RequirementsProduct LaunchQuality AuditingBiomedical EngineeringU.s. Food and Drug Administration (Fda)Quality AssuranceTechnology TransferCommercializationCardiologyVerification and Validation (V&V)21 Cfr Part 11RegulationsLife SciencesSterilizationRegulatory AffairsLifesciencesOrthopedicChange ControlR&DMarket DevelopmentCorrective and Preventive Action (Capa)BiocompatibilityBiopharmaceuticalsDesign of ExperimentsManufacturingClinical TrialsBiotechnologyQuality SystemV&VRegulatory SubmissionsIso 13485MicrobiologyHardware DiagnosticsQuality ControlSopOrthopedicsFda

ABOUT ANNE HOLLAND

Over the past 20 years, I have carefully cultivated a team of experts for QA Consulting who share integrity and enthusiasm for our work. I have handpicked each member of our staff for his or her diverse experience within our industry, as well as attention to detail. I can say with certainty that our consultants collectively provide unparalleled customer service as well as unique and creative solutions for projects or budgets of any scope or size. We love quality so you don’t have to! I also specialize as a medical device expert witness or as litigation support.

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Anne Holland — Founder and CEO at Qa Consulting, Inc in Austin, TX, US | Unifers