Principal Quality Engineer - Fca Air

Olympus Corporation of the Americas

WESTBOROUGH, MASSACHUSETTS, US
$104,061.00 - $145,685.00 / year; bonus potential;...
On-site
Fca air process
Regulatory requests for information
Cross-functional team leadership
The Principal Quality Engineer is responsible for driving complex projects to completion by effectively managing all aspects related to such initiatives within the Quality organization

Job Summary

  • The Principal Quality Engineer is responsible for driving complex projects to completion by effectively managing all aspects related to such initiatives within the Quality organization.
  • Supports the development and implementation of the global regulatory FCA related requests for additional information communication process and activities.
  • We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Matching Summary

The Principal Quality Engineer is responsible for driving complex projects to completion by effectively managing all aspects related to such initiatives within the Quality organization.

Salary

$104,061.00 - $145,685.00 / year; Bonus potential; Comprehensive benefits

Skills & Requirements

Must-have

  • FCA AIR process
  • regulatory requests for information
  • cross-functional team leadership
  • data analysis and trending
  • medical device complaint handling
  • root cause analysis

Nice-to-have

  • global outlook and integration
  • employee-centric mindset
  • holistic employee experience
  • strong interpersonal skills

Key Requirements

  • Bachelor's degree in science or engineering
  • 9+ years in medical device industry
  • Experience with US FDA, EU MDD/MDR, ISO 13485
  • Experience with CAPA process
  • Experience with Excel for data analysis
  • Experience in global organization collaboration

Work Rights

Not specified

Tailored Resume

Cover Letter