Quality Engineer Ii

fcpersepolis.site

Base: $77,570 - $113,740; bonus/equity: cash-based...
Quality management systems (qms)
Fda regulations
Iso, qsr, ul, mdd, tga
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.
  • This role involves monitoring manufacturing, reviewing changes to product documentation, leading validation protocols, and developing inspection techniques to ensure product integrity.
  • 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.

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

Base: $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)
  • FDA regulations
  • ISO, QSR, UL, MDD, TGA
  • statistical quality control
  • test method validations
  • non-conforming materials disposition

Nice-to-have

  • common set of values
  • unifies, embraces uniqueness
  • long-term success
  • work independently and in team

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter