Serve as the dedicated Quality Representative on cross-functional project teams, ensuring Design Control principles are meticulously applied to all Product/Process Changes and New Product Development initiatives
Job Summary
Serve as the dedicated Quality Representative on cross-functional project teams, ensuring Design Control principles are meticulously applied to all Product/Process Changes and New Product Development initiatives.
Craft, review, and approve detailed Product Documents including Design History Files that tell the complete story of our products.
Guide and develop staff members, sharing your expertise to build our next generation of quality professionals.
Matching Summary
Serve as the dedicated Quality Representative on cross-functional project teams, ensuring Design Control principles are meticulously applied to all Product/Process Changes and New Product Development initiatives.
Skills & Requirements
Must-have
Design Control principles
Product/Process Changes
New Product Development
Quality System Documents
CAPA and Audits
Product Documents
Design History Files
Process and Product Validations
Risk Assessments
Software Validation
Internal and Supplier Audits
Corrective and preventive action plans
Nice-to-have
Cross-functional collaboration
Team development and mentorship
Industry standards engagement
Proactive risk mitigation
Continuous improvement focus
Key Requirements
BS Degree in Engineering, Science or Technical Field
3 years of Quality Design Engineering experience
5 years of experience in FDA regulated environment