Staff Quality Engineer II (Hybrid) Join us at Becton, Dickinson, and Company, a global leader in medical technology. As a Staff Quality Engineer II, you'll play a vital role in our Wearable Injector platform, contributing to new product development and maintenance. Bring your expertise in design control, problem-solving, and analytical skills to ensure product quality through processes like validation, measurement system analysis, root cause analysis, and design verification.
Responsibilities:- Evaluate customer requirements and identify quality standards
- Release products during development activities
- Implement PS global procedures and standards for QE engineering
- Support audits and corrective actions
- Conduct Failure Investigations and problem-solving sessions
- Approve new design/process specifications
- Provide guidance to team members
- Design and perform development independently
- Liaise with Manufacturing PlantsDefine product control strategy and lead risk management activities
- Ensure design control elements are satisfied
- Perform process validation activities
- Evaluate test methods and develop systems related to project quality activities
- Support continuous improvement and customer-facing teams
- Ensure agreement terms are met
- Provide technical support from a quality perspective
Position Requirements
Education: BS degree in Engineering or other scientific field
Experience:
Quality Engineering experience or 12+ years in the industry (Medical Device/Pharmaceutical) Special Skills: Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMPKnowledge of design control principles Statistical methods for Quality Assurance Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management Knowledge and experience in manufacturing, project management, and engineering Good written and oral communication skills Excellent problem-solving and analytical skills Strong leadership capability Ability to handle multiple projects simultaneously in an unsupervised environment Become a maker of possible with us. Advance the world of health. Join BD and unleash your potential.
