Staff Quality Engineer II (Hybrid

Auctis
  • New Jersey
    30+ days ago

    Job Description

    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.

    Numbers & Facts

    LocationNew Jersey
    Websitehttps://www.auctis.net/

    Skills

    • Analysis Skillsunmatched
    • Biotech and Pharmaceuticalunmatched
    • Communication Skillsunmatched
    • Continuous Improvementunmatched
    • Corrective Actionunmatched
    • Customer Relationsunmatched
    • Customer/Client Researchunmatched
    • Design Verificationunmatched
    • Engineeringunmatched
    • Failure Mode and Effects Analysis (FMEA)unmatched
    • GMP (Good Manufacturing Practices)unmatched
    • ISO (International Organization for Standardization)unmatched
    • Industry Standardsunmatched
    • Leadershipunmatched
    • Manufacturingunmatched
    • Manufacturing Managementunmatched
    • Medical Equipmentunmatched
    • Multitaskingunmatched
    • People Managementunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Procedure Implementationunmatched
    • Process Validationunmatched
    • Product Controlunmatched
    • Product Developmentunmatched
    • Product Strategyunmatched
    • Project Engineeringunmatched
    • Project/Program Managementunmatched
    • Quality Assurance Methodologyunmatched
    • Quality Engineeringunmatched
    • Quality Metricsunmatched
    • Quality System Requirements (QSR)unmatched
    • Regulationsunmatched
    • Risk Managementunmatched
    • Root Cause Analysisunmatched
    • Six Sigmaunmatched
    • Systems Analysisunmatched
    • Technical Supportunmatched
    • Test Plan/Scheduleunmatched
    • Writing Skillsunmatched

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