Jenn Zuba

President @Cooperative Quality Solutions

Flagstaff, AZ, US
EMAILS
j•••@cooperativequality.com
MOBILE NUMBERS
+15•••••••47

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WORK HISTORY

Jul 2020 — Present

President @Cooperative Quality Solutions

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Flagstaff, AZ, US

Implement quality management systems for medical device start up companies. Execute quality management system continuous improvement, remediation, and gap assessments. Provide fractional quality assurance services.

EDUCATION

2002 — 2005

Rensselaer Polytechnic Institute

BS, Biomedical Engineering

2005 — 2006

Rensselaer Polytechnic Institute

MS, Biomedical Engineering

SKILLS

Project PlanningDesign for ManufacturingValidationIso 13485Medical DevicesProduct DevelopmentProject ManagementSolidworksDesign ControlProduct LaunchTechnical WritingCadHuman AnatomyManufacturingRBiomedical EngineeringMedical Device Product DevelopmentCross-Functional Team LeadershipFinite Element AnalysisFdaMechanical TestingRisk Management

ABOUT JENN ZUBA

Biomechanical engineer and medical device compliance expert with 20+ years of medical device experience including international standard development, quality system process creation and improvement, product development, and project management. Extremely detail oriented, proactive, and capable of balancing multiple high priority projects at once.Available for part-time remote consulting on medical device quality systems including quality system implementation for start-up companies and non-conformance and warning letter remediation.

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