Senior Quality Engineer

Integer

Plymouth, MN, United States
$114,675 - $168,190; not specified; comprehensive ...
Quality management systems (qms)
Fda regulations
Device history records (dhr)
Ensure Integer internal and external customer expectations are met or exceeded by identifying and evaluating procedures to ensure the production of quality product

Job Summary

  • Ensure Integer internal and external customer expectations are met or exceeded by identifying and evaluating procedures to ensure the production of quality product.
  • Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • The company provides innovative, high-quality medical technologies that enhance the lives of patients worldwide.

Matching Summary

Ensure Integer internal and external customer expectations are met or exceeded by identifying and evaluating procedures to ensure the production of quality product.

Salary

$114,675 - $168,190; Not specified; Comprehensive benefits package

Skills & Requirements

Must-have

  • Quality Management Systems (QMS)
  • FDA regulations
  • Device History Records (DHR)
  • Bill of Materials (BOM) review
  • Process validation
  • Test method validation
  • Root cause analysis

Nice-to-have

  • Collaborate with cross-functional teams
  • Positive, can-do attitude
  • Calm demeanor in high-energy environment
  • Subject matter expert recognition
  • Adherence to company values

Key Requirements

  • Bachelor's degree in engineering or related field
  • 7+ years of progressive engineering experience
  • 15+ years of relevant experience (if education requirement not met)
  • 6-Sigma (Green Belt minimum, Black Belt preferred)
  • Awareness of Domestic and International Regulations and Industry Standards

Work Rights

Not specified

Tailored Resume

Cover Letter