Quality Engineer Ii

Audioxnard

$77,570 - $113,740; bonus/equity: cash-based incen...
Quality management systems (qms)
Regulatory and standards requirements
Device history records (dhr)
The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance

Job Summary

  • The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.
  • The company fosters a culture that unifies, embraces uniqueness, and positions for long-term success through core values like Customer focus, Innovation, Collaboration, Inclusion, Candor, and Integrity.
  • The total rewards program includes base salary, cash-based incentive program, comprehensive benefits with immediate eligibility (medical, dental, vision, disability, life insurance, adoption benefits), parental leave, 401(k) with company matching, and paid time off.

Matching Summary

The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.

Salary

$77,570 - $113,740; Bonus/Equity: cash-based incentive program; Benefits: medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with company matching, 80 hours holidays, paid time off

Skills & Requirements

Must-have

  • Quality Management Systems (QMS)
  • Regulatory and Standards requirements
  • Device History Records (DHR)
  • Non-conforming material disposition
  • CAPA activities
  • Statistical quality control

Nice-to-have

  • Work independently and in team
  • Effective written and verbal communication
  • Time management
  • Continuous improvement projects

Key Requirements

  • Bachelor’s Degree in Engineering or related field
  • 2-5 years quality engineering experience
  • Medical device or regulated manufacturing experience
  • Competence in Quality Engineering Tools and Techniques
  • Knowledge of Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA)

Work Rights

Not specified

Tailored Resume

Cover Letter