Qa Engineer - 1

Chomonix

Austin, TX, US
Quality assurance procedures
Root cause analysis leadership
Compliance with gmp iso fda cmdr
This position is responsible for complex activities regarding the design, implementation, and maintenance of quality assurance procedures to ensure compliance with company standards and government regulations

Job Summary

  • This position is responsible for complex activities regarding the design, implementation, and maintenance of quality assurance procedures to ensure compliance with company standards and government regulations.
  • The role supports Operations/Manufacturing and serves as the QA representative on the Material Review Board, leading root cause analysis and corrective actions.
  • Enovis is an innovation-driven medical technology company dedicated to developing clinically differentiated solutions that generate better patient outcomes and transform workflows.

Matching Summary

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

Skills & Requirements

Must-have

  • Quality assurance procedures
  • Root cause analysis leadership
  • Compliance with GMP ISO FDA CMDR
  • Manufacturing process knowledge
  • Microsoft Office proficiency
  • Material Review Board representation
  • Ability to lift 50 lbs and physical tasks

Nice-to-have

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

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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