Sr. Staff Quality Engineer - New Product Development
BD
Durham, United States
Fully remote
Design controls
Risk management
Quality management system
The Senior Staff Quality Engineer is responsible for QA-related R&D activities from research through product launch, ensuring design controls and risk management principles are applied
Job Summary
The Senior Staff Quality Engineer is responsible for QA-related R&D activities from research through product launch, ensuring design controls and risk management principles are applied.
Serve as the quality cornerstone for multi-functional design teams, orchestrating comprehensive quality strategies throughout the design control lifecycle.
Build collaborative partnerships across functions to drive consensus and resolve sophisticated challenges efficiently, while curating impeccable technical files and Design History Files.
Matching Summary
The Senior Staff Quality Engineer is responsible for QA-related R&D activities from research through product launch, ensuring design controls and risk management principles are applied.
Skills & Requirements
Must-have
Design Controls
Risk Management
Quality Management System
Regulatory Compliance
Failure Investigations
Technical File Management
Nice-to-have
Lean or Six Sigma methodologies
Cybersecurity initiatives
Iterative development environments
Mentorship capabilities
Key Requirements
Bachelor's degree in engineering and 15 years' experience
Master's degree in engineering and 10 years' experience