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Auctis Corporation

STAFF QUALITY ENGINEER II (HYBRID

Auctis Corporation, Franklin Lakes, NJ, United States


About the job STAFF QUALITY ENGINEER II (HYBRID

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.