Quality Engineer - job 1 of 3

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

Experienced Quality Engineer with a strong background in the Medical Devices industry. 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).
• Collaborate with cross-functional teams to ensure timely and compliant project execution.

• Bachelor’s or Master’s degree in Engineering or a related field.
• Minimum of 5 years of experience as a Quality Engineer in a regulated industry.
• Bilingual – fluent in English and Spanish.
• Strong technical writing and documentation skills.
• Hands-on experience with equipment and product transfer processes.

All your information will be kept confidential according to EEO guidelines.