Quality Engineer Ii

H1BConnect

Plymouth, MN, United States
Base: $77,570- $113,740; bonus/equity: cash-based ...
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.
  • Lead generation and completion of protocols and reports for test method validations and interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies.
  • Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success, including base salary, a cash-based incentive program, and a comprehensive benefits package.

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

Base: $77,570- $113,740; Bonus/Equity: cash-based incentive program; Benefits: medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with company matching, 80 hours holidays, paid time off

Skills & Requirements

Must-have

  • Quality System Requirements
  • Medical Device Manufacturing
  • Regulatory and Standards Compliance
  • Device History Records
  • Test Method Validations
  • Process Validations and Capability Studies
  • Non-conforming Material Disposition
  • CAPA Activities
  • Statistical Quality Control

Nice-to-have

  • Customer Success Focus
  • Innovation and Better Solutions
  • Collaboration and Teamwork
  • Respectful Interaction
  • Open and Honest Communication
  • Integrity and Doing Things Right

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter