Staff Design Quality Engineer
Becton Dickinson & Co
Becton Dickinson seeks a Staff Design Quality Engineer to lead quality engineering initiatives and provide technical guidance on medical device design, validation, and compliance. The role supports product development from early-stage innovation through manufacturing scale-up and regulatory submission.
Responsibilities
- Provide technical leadership and mentorship to quality engineers, technicians, and inspectors
- Lead quality engineering projects enhancing systems, procedures, and regulatory compliance processes
- Develop test protocols and reports supporting FDA and international regulatory submissions
- Create and execute Design Verification and Validation protocols, analyzing results for design acceptability
- Lead risk management activities including DFMEA, AFMEA, and PFMEA development
Requirements
- Bachelor's degree and 8 years quality engineering experience, or Master's degree and 6 years experience
- Expertise in design controls, product/process validation, and risk management
- Advanced proficiency with statistical techniques and Six Sigma tools
- Deep knowledge of FDA QSR, ISO 13485, and ISO 9001 requirements
- Strong understanding of design control from concept through post-market activities
- Ability to travel as required
- Minimum 4 days per week on-site presence
Vacancy posted 13 days ago
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