Quality Engineer Ii

985fm.ca

Plymouth, MN, United States
$77,570 - $113,740; not specified; medical, dental...
Quality system requirements adherence
Regulatory and standards compliance
Device history records maintenance
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 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 adherence
  • Regulatory and Standards compliance
  • Device History Records maintenance
  • Process validation and capability studies
  • Non-conforming material disposition
  • Complaint investigation leadership

Nice-to-have

  • Continuous improvement participation
  • Supplier quality problem resolution
  • Mentoring quality inspectors and technicians
  • Teamwork and independent work ability

Key Requirements

  • Bachelor’s Degree in Engineering or related field
  • 2-5 years quality engineering experience
  • Medical device or regulated manufacturing experience preferred
  • Proficiency in Microsoft Office and Minitab

Work Rights

Not specified

Tailored Resume

Cover Letter