Quality Engineer Ii

Byethost9

Base: $77,570- $113,740; bonus/equity: cash-based ...
Quality system requirements adherence
Regulatory and standards compliance
Dmr compliance monitoring
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 test method validations.
  • The company offers a comprehensive total rewards program including base salary, incentive program, medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with 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

Skills & Requirements

Must-have

  • Quality System requirements adherence
  • Regulatory and Standards compliance
  • DMR compliance monitoring
  • Non-conforming material disposition
  • CAPA activities participation
  • Statistical quality control application

Nice-to-have

  • Work independently and in team
  • Effective written and verbal communication
  • Time management skills
  • Continuous improvement projects participation
  • Mentoring quality inspectors and technicians

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter