JT321 - QUALITY ENGINEER II

United States·Poncemid

EngineeringQuality Engineer

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Quick Summary

Key Responsibilities

The Contingent Engineer II will provide engineering support for validation,

Requirements Summary

Execute validation and qualification activities for equipment, processes, test methods, and manufacturing systems. Develop, revie

Technical Tools

EngineeringQuality Engineer

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities

~1 min read

→Working knowledge and experience with IQ/OQ/PQ protocol development and execution.

→Knowledge of process characterization and Design of Experiments (DOE) methodologies.

→Experience with Test Method Validation (TMV) and Inspection Method Validation (IMV).

→Proficiency in Minitab for statistical analysis, data interpretation, and process evaluation.

→Strong technical writing and documentation skills.

→Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.

→Strong verbal and written communication skills.

→Fully bilingual in English and Spanish (written and spoken).

→Preferred Qualifications

→Experience in medical device manufacturing.

→Knowledge of FDA regulations, Good Manufacturing Practices (GMP), and ISO 13485 standards.

→Familiarity with risk management tools, including Failure Mode and Effects Analysis (FMEA) and risk assessments.

→Experience with Microsoft Project.

→Previous experience supporting validation and process improvement projects in a regulated manufacturing environment.

→First Shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.