Medical Device Quality Engineer

Enovis Corporation

Austin, TX, US
Quality assurance procedures
Nonconforming material evaluation
Process and equipment validation
This position is responsible for the design, implementation, and maintenance of quality assurance procedures and work instructions to ensure safety, quality, and compliance with company standards and government regulations

Job Summary

  • This position is responsible for the design, implementation, and maintenance of quality assurance procedures and work instructions to ensure safety, quality, and compliance with company standards and government regulations.
  • Essential duties include evaluating nonconforming material, performing data analysis to identify trends, authoring and conducting process and equipment validations, and leading root cause analysis and CAPA investigations.
  • The role requires a Bachelor's in Science or Engineering with 3+ years of experience in a regulated industry, with preferred knowledge of ISO 13485, technical writing, and specific manufacturing processes.

Matching Summary

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

Skills & Requirements

Must-have

  • Quality Assurance Procedures
  • Nonconforming Material Evaluation
  • Process and Equipment Validation
  • ISO 13485 knowledge
  • Manufacturing Process Knowledge
  • English Fluency (Written and Verbal)

Nice-to-have

  • Continuous Improvement Culture
  • Problem-Solving Skills
  • Customer Service Excellence
  • Professional Ethics and Demeanor

Key Requirements

  • Bachelor's in Science or Engineering
  • 3+ years of experience
  • Medical Device, Aeronautics, or Automotive background
  • CQE, Lean, or 6 Sigma Certification (Preferred)

Work Rights

Not specified

Tailored Resume

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