Quality Engineer Ii

724842

Plymouth, MN, United States
$77,570 - $113,740; bonus/equity: cash-based incen...
Quality system requirements adherence
Medical device manufacturing compliance
Regulatory and standards compliance
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 inspections, monitoring manufacturing compliance, reviewing changes to product documentation, and leading the generation of test method validation protocols.
  • The company offers a comprehensive total rewards program including base salary, cash-based incentive program, and a comprehensive benefits package with immediate eligibility for medical, dental, vision, 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

$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, paid time off

Skills & Requirements

Must-have

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

Nice-to-have

  • Customer Success Focus
  • Innovation and Better Solutions
  • Collaboration and Team Success
  • Respectful Interaction
  • Open and Honest Communication
  • Integrity in Actions

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter