Quality Engineer

Experienced Quality Engineer with a strong background in the Medical Devices industry, particularly in the transfer of equipment and products to new facilities. Proven ability to lead and execute commissioning and qualification activities in compliance with regulatory and quality standards. Skilled in conducting thorough investigations to identify root causes, ensure corrective actions, and maintain compliance with internal and external requirements.

Key Responsibilities:

• Conduct investigations related to quality issues, deviations, and non-conformances.
• Verify quality documentation or regulations.
• Complete assessments and engineering or documents’ changes.
• Develop and execute commissioning documentation for facilities and utilities.
• Prepare and manage equipment qualification protocols and reports (IQ/OQ/PQ).
• Oversee the transfer and validation of equipment and products to new facilities.
• Collaborate with cross-functional teams to ensure timely and compliant project execution.