Quality Engineer Ii; Hybrid

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 Plants
• Define 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, GMP
• Knowledge 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.