Sr. Quality Engineer

Hi Tech IT - An Initiative to Digitise

Carol Stream, United States
$92,700.00 - $152,900.00 usd annual; not specified...
Fully remote
21 cfr 820 and 803
Iso 9001/13485
Eu mdr
The Sr. Quality Engineer will be responsible for ensuring the quality and reliability of Bard Brachytherapy products through the application of advanced quality engineering principles and methodologies

Job Summary

  • The Sr. Quality Engineer will be responsible for ensuring the quality and reliability of Bard Brachytherapy products through the application of advanced quality engineering principles and methodologies.
  • Responsibilities include supporting Design Control projects and providing essential support to the Quality System, Document Control, Manufacturing, and Investigations.
  • BD is one of the largest global medical technology companies in the world, advancing the world of health with transformative solutions.

Matching Summary

The Sr. Quality Engineer will be responsible for ensuring the quality and reliability of Bard Brachytherapy products through the application of advanced quality engineering principles and methodologies.

Salary

$92,700.00 - $152,900.00 USD Annual; Not specified; Not specified

Skills & Requirements

Must-have

  • 21 CFR 820 and 803
  • ISO 9001/13485
  • EU MDR
  • Design Control
  • Risk Management
  • CAPA
  • Root Cause Analysis

Nice-to-have

  • Collaboration with cross-functional teams
  • Mentorship of junior engineers
  • Statistical software proficiency
  • ASQ certifications

Key Requirements

  • Bachelor's degree in Engineering
  • 5+ years of experience in Quality Engineering
  • Medical device industry experience
  • FDA QSR (21 CFR Part 820)
  • ISO 13485
  • ISO 14971
  • Process validation (IQ, OQ, PQ)
  • Statistical Process Control (SPC)

Work Rights

Not specified

Tailored Resume

Cover Letter