Quality Engineer Ii

Integer

Plymouth, MN, United States
Base: $77,570 - $113,740; bonus/equity: cash-based...
Quality system requirements adherence
Medical device manufacturing compliance
Regulatory and standards requirements
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.
  • This role involves supporting regulatory and agency inspections, monitoring manufacturing, reviewing changes to product documentation, and leading generation of test method validation protocols.
  • The company offers a comprehensive total rewards program including base salary, incentive program, medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with company match, paid holidays, and paid time off.

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

Skills & Requirements

Must-have

  • Quality System requirements adherence
  • Medical device manufacturing compliance
  • Regulatory and Standards requirements
  • Product design and manufacturing quality control
  • Test method validation protocols
  • Process validation and capability studies
  • Inspection techniques and procedures

Nice-to-have

  • Continuous improvement project participation
  • Supplier quality problem resolution
  • Statistical quality control application
  • Mentoring quality inspectors and technicians
  • Teamwork and collaboration

Key Requirements

  • Bachelor’s Degree in Engineering or related field
  • 2-5 years quality engineering experience
  • Proficiency in Microsoft Office and Minitab
  • Competence in Quality Engineering Tools and Techniques
  • Good knowledge of Domestic and International Regulations and Industry Standards

Work Rights

Not specified

Tailored Resume

Cover Letter