Quality Engineer Ii

828

Plymouth, MN, United States
$77,570 - $113,740; not specified; medical, dental...
Quality system requirements
Medical device manufacturing
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, and interfacing with Manufacturing Engineers to review processes for new and existing products.
  • The company offers a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits, along with a 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

$77,570 - $113,740; Not specified; Medical, dental, vision, disability, life insurance, adoption benefits, 401(k) with match, paid time off, holidays

Skills & Requirements

Must-have

  • Quality System Requirements
  • Medical Device Manufacturing
  • Regulatory and Standards Compliance
  • Product Design and Manufacturing Quality
  • Non-conforming Material Disposition
  • CAPA Activities

Nice-to-have

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

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter