Sr. Staff Quality Engineer - New Product Development
BD
Durham, NC, United States
Fully remote
Design controls and risk management
Quality management system compliance
Root cause investigations and problem-solving
The Senior Staff Quality Engineer is a key member of the New Product Development Team responsible for QA-related R&D activities from research through product launch
Job Summary
The Senior Staff Quality Engineer is a key member of the New Product Development Team responsible for QA-related R&D activities from research through product launch.
This position ensures that design controls and risk management principles are applied to new product development and sustaining engineering projects while supporting broader QMS activities.
At BD, employees are supported to learn, grow, and thrive in a culture that values authenticity, accountability, and continuous improvement.
Matching Summary
The Senior Staff Quality Engineer is a key member of the New Product Development Team responsible for QA-related R&D activities from research through product launch.
Skills & Requirements
Must-have
Design controls and risk management
Quality Management System compliance
Root cause investigations and problem-solving
Regulatory frameworks including EU MDR and ISO standards
New product development quality assurance
Statistical analysis and sampling methodologies
Nice-to-have
Lean or Six Sigma methodologies
Cybersecurity in regulated medical devices
Hardware/software systems integration
Scaled Agile Framework (SAFe) experience
Mentoring and knowledge sharing
Quality-by-design approaches
Key Requirements
Bachelor’s degree in engineering with 15 years experience
OR Master’s degree in engineering with 10 years experience
Experience in R&D development, Quality Engineering, and Design Controls
Ability to travel up to 10%
Experience applying Lean or Six Sigma methodologies
SAFe certifications preferred
Work Rights
Must be fully vaccinated against COVID-19 where applicable