Quality Engineer Ii

Audinewmarket

$77,570 - $113,740; not specified; not specified p...
Quality management systems
Fda regulations
Device history records
The company fosters a culture that unifies, embraces uniqueness, and positions for long-term success through common values like Customer focus, Innovation, Collaboration, Inclusion, Candor, and Integrity

Job Summary

  • The company fosters a culture that unifies, embraces uniqueness, and positions for long-term success through common values like Customer focus, Innovation, Collaboration, Inclusion, Candor, and Integrity.
  • This role provides Quality Engineering support for medical device manufacturing operations, ensuring compliance with regulatory and standards requirements, and includes providing work direction for technicians/inspectors.
  • The total rewards program includes base salary, cash-based incentive program, comprehensive benefits with immediate eligibility, 401(k) with company matching, and paid time off including holidays.

Matching Summary

The company fosters a culture that unifies, embraces uniqueness, and positions for long-term success through common values like Customer focus, Innovation, Collaboration, Inclusion, Candor, and Integrity.

Salary

$77,570 - $113,740; Not specified; Not specified

Skills & Requirements

Must-have

  • Quality Management Systems
  • FDA regulations
  • Device History Records
  • test method validations
  • non-conforming materials disposition
  • CAPA activities
  • statistical quality control

Nice-to-have

  • work independently and in team
  • communicate written and verbally
  • manage time effectively
  • continuous improvement projects
  • resolution of quality problems

Key Requirements

  • Bachelor’s Degree in Engineering or related field
  • 2-5 years quality engineering experience
  • medical device or regulated manufacturing experience
  • Proficient in Microsoft Office and Minitab

Work Rights

Not specified

Tailored Resume

Cover Letter