Engineer -inter

US-NJ-Mahwah
2 weeks ago
Job ID
2017-27785
Category
Engineering
Position Type
Contract (Full-Time)
# of Openings
1

Overview

Quality Engineer responsible for review and approval of product drawing changes based on Unique Device Identification (UDI) requirements. Ensure timely closure of updates to comply with FDA requirements. Perform change control activities. Must demonstrate strong knowledge in GD&T and reading CAD drawings.

Qualifications

  • 3+ years of experience as a Quality Engineer in a regulated design environment.
  • Prefer experience with medical device product development life cycle.
  • Knowledge of FDA QSR, ISO 13485 Design Control Procedures.
  • Demonstrated ability to read and interpret CAD drawings.
  • Demonstrated ability in GD&T. Demonstrated ability to advocate product excellence and quality
  • Demonstrated ability to effectively work cross functionally with other departments including Advanced Operations, Product Development, Regulatory and Marketing.
  • Demonstrated problem-solving and troubleshooting skills.
  • Demonstrated interpersonal and communication skills.
  • Demonstrated a positive, energetic approach to teamwork.
  • Demonstrated ability to learn quickly and multi-task
  • Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
  • Computer proficiency with MS Office.

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