Quality Engineer Ii

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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 test method validations.
  • The total rewards program includes base salary, cash-based incentive program, comprehensive benefits with immediate eligibility, and 401(k) plan with company matching contributions.

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: comprehensive benefits package

Skills & Requirements

Must-have

  • Quality System requirements adherence
  • Medical device manufacturing compliance
  • Regulatory and Standards requirements
  • Device History Records maintenance
  • Non-conforming material disposition
  • CAPA activities participation

Nice-to-have

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

Key Requirements

  • Bachelor’s Degree in Engineering or related field
  • 2-5 years quality engineering experience
  • Medical device or regulated manufacturing experience
  • Competence in Quality Engineering Tools and Techniques
  • Knowledge of Domestic and International Regulations and Industry Standards

Work Rights

Not specified

Tailored Resume

Cover Letter