Quality Engineer

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 validations.

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Ensure compliance with Design Control and Quality System requirements.
• Review and approve validation protocols and reports.
• Support DFMEA, PFMEA, and risk management activities.
• Develop and approve control plans and inspection strategies.
• Participate in design reviews and transfer reviews.
• Support release readiness and manufacturing site qualification activities.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!

Are you the Next Piece?