Staff Quality Engineer II (Hybrid)
Location: Franklin Lakes, New Jersey, United States Company: Becton, Dickinson, and Company HR: Mable Farish
Base Salary: USD $126,600 to $130,000
Relocation Assistance: Possible for ideal candidate
Required Experience: 10+ to 15 years
Minimum Education: Bachelor's Degree
Industry:
Medical Equipment / Devices
Job Category: Manufacturing - Quality
Description: 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.