Quality Engineer Ii

813

Plymouth, MN, United States
$77,570 - $113,740; not specified; comprehensive b...
Quality system requirements adherence
Medical device manufacturing compliance
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 a comprehensive benefits package with immediate eligibility.

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; Comprehensive benefits package

Skills & Requirements

Must-have

  • Quality System Requirements Adherence
  • Medical Device Manufacturing Compliance
  • Regulatory and Standards Compliance
  • Test Method Validation Protocols
  • Process Validation and Capability Studies
  • Non-conforming Material Disposition
  • CAPA Activities Participation

Nice-to-have

  • Customer Success Focus
  • Innovation and Better Solutions
  • Collaboration and Team Success
  • Respectful Interaction
  • Open and Honest Communication
  • Integrity in Actions

Key Requirements

  • Bachelor’s Degree in Engineering
  • 2-5 years quality engineering experience
  • Medical device or regulated manufacturing experience
  • Competence in Quality Engineering Tools
  • Knowledge of Regulations and Standards (ISO, QSR, etc.)
  • Proficient in Microsoft Office and Minitab

Work Rights

Not specified

Tailored Resume

Cover Letter