Senior Quality Engineer

828

Minneapolis, MN, United States
Base: not specified; bonus/equity: cash-based ince...
Quality management systems (qms)
Fda regulations
Device history records (dhr)
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.
  • Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success.

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.

Salary

Base: Not specified; Bonus/Equity: cash-based incentive program; Benefits: comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

Skills & Requirements

Must-have

  • Quality Management Systems (QMS)
  • FDA regulations
  • Device History Records (DHR)
  • product and process improvement
  • risk analyses and Control plans
  • product, process, and test method validations
  • non-conforming materials disposition
  • CAPA activities

Nice-to-have

  • customer success focus
  • collaborative solutions
  • respectful interaction
  • open and honest communication
  • people management interest

Key Requirements

  • Statistical techniques
  • RCA approaches
  • Workload management
  • Soft skills

Work Rights

Not specified

Tailored Resume

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