Medical Device Quality Engineer

Pethospitaloflamesa

Austin, TX, US
Quality assurance procedures
Root cause analysis leadership
Compliance with gmp iso fda cmdr
Enovis Corporation is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows

Job Summary

  • Enovis Corporation is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows.
  • This position is responsible for complex activities regarding quality assurance to ensure safety, quality, and compliance with company standards and government regulations while supporting Operations and Manufacturing.
  • The role involves evaluating nonconforming materials, leading root cause analysis and corrective actions, and supporting manufacturing to resolve quality or compliance issues.

Matching Summary

Enovis Corporation is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows.

Skills & Requirements

Must-have

  • Quality assurance procedures
  • Root cause analysis leadership
  • Compliance with GMP ISO FDA CMDR
  • Process and equipment validations
  • Microsoft Office Suite proficiency
  • Ability to lift 50 lbs and physical tasks

Nice-to-have

  • Knowledge of Solidworks and ePDM
  • Experience with Oracle R12 and Agile PLM
  • Lean or Six Sigma certification
  • Professional ethics and demeanor
  • Excellent customer service skills
  • Technical writing best practices

Key Requirements

  • Bachelor’s in Science or Engineering
  • 3+ years experience in regulated industry
  • Background in Medical Device or similar regulated industry
  • Preferred knowledge of ISO 13485 quality standards
  • CQE, Lean, or Six Sigma Certification preferred
  • Must communicate fluently in English
  • Office based in Austin, TX

Work Rights

Not specified

Tailored Resume

Cover Letter