Job Summary

Responsible for development quality assurance activities supporting product development under the direction of a project leader or manager. Good communication, teamwork and organizational skills are essential. This role supports design verification and validation testing, report generation, and document approvals within Vault and Windchill. 

Principal Duties and Responsibilities 

• Designing verification and validation testing to confirm product requirements are met 
• Generating verification and validation reports that clearly document methods, results, and conclusions 
• Routing and supporting approvals for quality and development documentation within Vault and Windchill 
• Supporting design assurance activities to ensure testing, documentation, and change control align with quality system requirements 
• Collaborating with cross-functional teams to maintain timely completion of QA deliverables for development projects 

Skills:

Expected Areas of Competence (i.e. KSAs) 

• Knowledge of design verification and validation planning, execution, and documentation practices
• Ability to prepare clear, accurate, and compliant test reports and supporting quality records
• Ability to work effectively with development, regulatory, and quality teams to complete project deliverables on schedule 
• Working knowledge of document routing, review, and approval workflows in Vault and Windchill
• Understanding of quality system requirements applicable to design control, testing, and document approval activities
• Microsoft Office Suite, Vault, and Windchill

Education/ Experience Requirements

• B.S. degree from an ABET accredited school (or global equivalent) in an engineering or science discipline, as preferred by the specific department and 0 to 3 years of experience.

Travel Requirements 

Up to 10%