Medical Device Quality Assurance Engineer

Enovis Corporation

Austin, Texas, United States
Not specified; not specified; comprehensive benefi...
Bachelor's in science or engineering degree
7-10 years of manufacturing experience
Experience with iq/oq/pq validation
This position is responsible for the design, implementation, and maintenance of quality assurance procedures to ensure safety and compliance with government regulations

Job Summary

  • This position is responsible for the design, implementation, and maintenance of quality assurance procedures to ensure safety and compliance with government regulations.
  • The role involves leading root cause analysis investigations and serving as the QA representative on the Material Review Board.
  • Enovis offers a comprehensive benefits package including medical insurance, dental, vision, and a 401(k) plan.

Matching Summary

This position is responsible for the design, implementation, and maintenance of quality assurance procedures to ensure safety and compliance with government regulations.

Salary

Not specified; Not specified; Comprehensive benefits package including medical, dental, vision, and 401(k)

Skills & Requirements

Must-have

  • Bachelor's in Science or Engineering degree
  • 7-10 years of manufacturing experience
  • Experience with IQ/OQ/PQ validation
  • Knowledge of ISO 13485 standards
  • Root cause analysis and CAPA leadership
  • Metrology and precision machining knowledge

Nice-to-have

  • Solidworks and Agile PLM software proficiency
  • CQE, Lean, or Six Sigma certification
  • Excellent written and verbal communication
  • Ability to lift 50 lbs and bend overhead
  • Professional ethics and customer service skills

Key Requirements

  • Bachelor's degree in Science or Engineering
  • 7-10 years of relevant industry experience
  • Full-time work authorization in the United States
  • No visa sponsorship provided

Work Rights

Must have full-time work authorization in the US without sponsorship

Tailored Resume

Cover Letter