Quality Engineer

Flexible & Integrated Technical Services, LLC

📍 Ponce, Puerto Rico, Puerto Rico On-Site ⏳ 1d ago
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Job Description

For Quality Engineering services in the Manufacturing area.

WHAT MAKES YOU A FIT:

The Technical Part:

  • Bachelor's degree in Engineering, Quality, Biomedical Engineering, or related discipline.
  • 5+ years of experience in Quality Engineering within the medical device industry.
  • Strong knowledge of Design Controls, Risk Management, Validation, and Regulatory requirements.
  • Familiarity with FDA 21 CFR Part 820, ISO 13485, and risk management methodologies.
  • Shift: Administrative, and according to business needs.
  • Experience in:
    • Supporting product transfers, design changes, and process