Senior Quality Engineer

900

Minneapolis, MN, United States
Quality management systems (qms)
Fda regulations
Product design and manufacturing quality
Adheres to Integer Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements

Job Summary

  • Adheres to Integer Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
  • Leads product and process improvement initiatives and Implements various product and process improvement methodologies.
  • The company provides a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.

Matching Summary

Adheres to Integer Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.

Skills & Requirements

Must-have

  • Quality Management Systems (QMS)
  • FDA regulations
  • Product design and manufacturing quality
  • Device History Records (DHR)
  • Risk analyses and Control plans
  • Product, process, and test method validations
  • Non-conforming materials disposition
  • CAPA activities

Nice-to-have

  • Customer success focus
  • Innovation and collaboration
  • Respectful interaction
  • Open and honest communication
  • Doing the right things

Key Requirements

  • Strong Statistical techniques
  • Use of RCA approaches
  • Excellent Workload management
  • Good Soft skills

Work Rights

Not specified

Tailored Resume

Cover Letter