Quality Engineer Ii

Grffeapp

Base: $77,570- $113,740; bonus/equity: cash-based ...
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.
  • This role involves supporting regulatory and agency inspections, monitoring manufacturing, reviewing changes to product documentation, and leading generation of protocols and reports for test method validations.
  • The company offers a comprehensive total rewards program including base salary, cash-based incentive, medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with company matching, holidays, 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

Skills & Requirements

Must-have

  • Quality Management Systems (QMS)
  • Regulatory and Standards requirements
  • Device History Records (DHR)
  • test method validations
  • process validations and capability studies
  • non-conforming materials disposition
  • CAPA activities

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
  • Proficient in Microsoft Office and Minitab

Work Rights

Not specified

Tailored Resume

Cover Letter