Quality Engineer Ii

Integer

Base: $77,570 - $113,740; bonus/equity: cash-based...
Quality system requirements adherence
Medical device manufacturing compliance
Regulatory and standards requirements
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 validation protocols.
  • The total rewards program includes base salary, cash-based incentive, comprehensive benefits with immediate eligibility, parental leave, and 401(k) with company matching.

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 System Requirements Adherence
  • Medical Device Manufacturing Compliance
  • Regulatory and Standards Requirements
  • Device History Records Maintenance
  • Non-conforming Material Disposition
  • Root Cause Analysis
  • Statistical Quality Control Application

Nice-to-have

  • Common Set of Values Culture
  • Customer Success Focus
  • Innovation and Better Solutions
  • Respectful Interaction
  • Open and Honest Communication
  • Doing the Right Things

Key Requirements

  • Bachelor’s Degree in Engineering or related field
  • 2-5 years quality engineering experience
  • Medical device or regulated manufacturing experience preferred
  • Competence in Quality Engineering Tools and Techniques
  • Good knowledge of Domestic and International Regulations
  • Proficient in Microsoft Office and Minitab

Work Rights

Not specified

Tailored Resume

Cover Letter