Quality Engineer Ii

809

Plymouth, MN, United States
$77,570 - $113,740; not specified; medical, dental...
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 leading generation and completion of protocols and reports for test method validations, interfacing with Manufacturing Engineers, and developing inspection techniques and procedures.
  • The company offers a comprehensive total rewards program including base salary, cash-based incentive program, and a comprehensive benefits package with immediate eligibility.

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; Not specified; 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 Compliance
  • Device History Records Maintenance
  • Test Method Validation Protocols
  • Non-conforming Material Disposition
  • CAPA Activities Participation

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
  • Proficient in Microsoft Office and Minitab

Work Rights

Not specified

Tailored Resume

Cover Letter