Sr Quality Engineer

Company Description

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!

Job Description

Experienced Sr. 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.

Key Responsibilities:

• 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.

Qualifications

• Bachelor’s or Master’s degree in Engineering or a related field.
• Minimum of 9 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.

Additional Information

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