Cade Wright Email & Phone Number

Boston, Ma, Us

Boston, Ma, Us

Medical Device QE /Validation Consultant

Norwood, Massachusetts, Us

Lead engineer, validating new equipment.

Boston, Massachusetts, Us

Remote role supporting California office for CARDIVA.Strong focus on DHF remediation, EU MDR and IVDR compliance, design changes and risk assessment within RMF.

Princeton, New Jersey, Us

Tissue Technologies Manufacturing Quality Engineer

St Petersburg, Florida, Us

-Factory Acceptance Testing Activities-Responsible for writing and execution of Commissioning and Qualification Plans and Test Cases-Responsible for drafting validation summary reports-Software Source Code Review and Electronic Identification Logs-Responsible for drafting Interchangeability Studies and Summary Reports

Abbott Park, Illinois, Us

Providence, Ri, Us

Design Controls (design verification testing), Risk Management and Quality roles.

St. Petersburg, Florida, Us

Quality - Injection molded medical devices and components.

Marlborough, Massachusetts, Us

Test Method Validation Engineering Consultant in Medical Device Industry

Gothenburg, Se

• Responsible for validating test methods utilized at incoming inspections for sub-assemblies and finished medical device product (Vascular and Endovascular products such as- Stents/Catheters/Chest Drains/Vascular Grafts/Components).• Responsible for creating test methodology or writing No Validation Rationales.• Utilized Minitab software and six sigma methodologies to analyze and report validation data.• Responsible for Equipment Validation (IQ, OQ) and Process Validation Activities.• Responsible for selecting materials and suppliers that meets internal and project requirements.• Troubleshooting Equipment Issues and Non-conformances, and Calibration for test equipment.• Design Verification and Qualification of Tooling and Fixtures.• Worked with CAPA engineers to support CAPA activities such as root cause analysis, implementing changes to design/ process/test and validating the suggested changes and methodologies.• Revise and submit DCO’s, and update risk management information as needed.• Supported project activities in accordance with corporate and FDA requirements.

Gothenburg, Se

TMV, DHF, Risk Management, Equipment Validations