Quality Engineer II (Hy-brid) – 3184268

Job ID: 3184268

Fulltime Onsite Opportunity with Paid Relocation

Quality Engineer II (Hybrid) – Franklin Lakes, New Jersey

Industry: Medical Equipment / Devices

Job Category: Manufacturing – Quality

Our client, a leading medical technology company with many Award-Winning Clients all over, is seeking a talented individual for the position of Quality Engineer II in Franklin Lakes, New Jersey.

Main Responsibilities:

  • Evaluate customer requirements to identify applicable quality standards
  • Serve as a key team member
  • Release product during development activities
  • Realize quality functional reviews
  • Ensure implementation of global procedures and standards for QE engineering activities
  • Provide support to internal, regulatory body, and customer audits, along with associated corrective actions.
  • Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products
  • Consistently apply technical principles, theories, concepts, and quality sciences/tools
  • Review and have Quality Engineering approval authority for new and modified design/process specifications
  • Contribute to the completion of specific programs and projects
  • Ensure quality conduct of projects, including design, data summary and interpretation, and report generation
  • Independently determine and develop an approach to a solution
  • Provide guidance and work direction to other team members
  • Design and perform development working independently within defined parameters
  • Liaise with Manufacturing Plants
  • Provide functional support to cross-functional teams
  • Define product control strategy
  • Lead risk management activities
  • Ensure design control elements are satisfied
  • Ensure/perform process validation activities
  • Develop/perform supplier qualification plans
  • Evaluate test methods used in project activities
  • Develop systems, processes, and procedures related to project quality activities.
  • Support continuous improvement of current products and practices
  • Ensure the terms of the agreement are met
  • Support customer-facing teams by providing technical support from a quality perspective.
  • Share risk mitigation strategies and control plans for the device with customers as applicable.

Position Requirements:

  • Education: BS degree in Engineering or another scientific field
  • Experience: Quality Engineering experience or 12+ years industry experience (Medical Device/Pharmaceutical)
  • Special Skills:
    • Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMP
    • Knowledge of design control principles.
    • Thorough understanding of 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
    • Must possess excellent oral and written communication skills, and supervisory/leadership capability.
    • Ability to handle multiple projects simultaneously in an unsupervised environment.

Job ID: 3184268

Job Type: Full Time
Job Location: Franklin Lakes
State: New Jersey

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