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Quality Engineer at QRC Group, Inc

Cidra, Puerto Rico, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Jan, 26

Salary

0.0

Posted On

04 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Medical Devices, Regulatory Compliance, Technical Writing, Root Cause Analysis, Corrective Actions, Commissioning, Qualification, Documentation, Cross-Functional Collaboration, Investigations, Equipment Qualification, Deviation Management, Non-Conformance Management, Assessment, Engineering Changes

Industry

Staffing and Recruiting

Description

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

Responsibilities

The Quality Engineer will conduct investigations related to quality issues and verify quality documentation. They will also develop and execute commissioning documentation and manage equipment qualification protocols.