Quality Engineer Ii

Integer

Base: $77,570 - $113,740; bonus/equity: cash-based...
Bachelor's degree in engineering
2-5 years quality engineering experience
Knowledge of fda regulations and iso standards
The primary purpose of this job is to provide Quality Engineering support for Operations to ensure adherence to Quality System requirements for medical device manufacturing

Job Summary

  • The primary purpose of this job is to provide Quality Engineering support for Operations to ensure adherence to Quality System requirements for medical device manufacturing.
  • The role involves leading the generation and completion of protocols for test method validations and reviewing changes to Bill of Materials and Assembly Procedures.
  • The company offers a comprehensive benefits package including medical, dental, vision, disability, life insurance, and immediate eligibility for a 401(k) plan with company matching.

Matching Summary

The primary purpose of this job is to provide Quality Engineering support for Operations to ensure adherence to Quality System requirements for medical device manufacturing.

Salary

Base: $77,570 - $113,740; Bonus/Equity: Cash-based incentive program supporting pay-for-performance philosophy; Benefits: Medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with matching

Skills & Requirements

Must-have

  • Bachelor's Degree in Engineering
  • 2-5 years quality engineering experience
  • Knowledge of FDA regulations and ISO standards
  • Experience with QMS and EMS systems
  • Proficiency in Minitab and statistical tools

Nice-to-have

  • Ability to work independently and in teams
  • Strong written and verbal communication skills
  • Mentoring experience for technicians and inspectors
  • Participation in continuous improvement projects

Key Requirements

  • Minimum Bachelor's Degree in Engineering or related field
  • 2-5 years of quality engineering experience
  • Preferably in medical device or regulated manufacturing
  • Competence in Domestic and International Regulations (ISO, QSR, UL)

Work Rights

Not specified

Tailored Resume

Cover Letter