JT321 - QUALITY ENGINEER II

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:
The Contingent Engineer II will provide engineering support for validation, qualification, and process improvement activities within a regulated manufacturing environment. This role involves executing validation protocols, performing statistical analyses, preparing technical documentation, and collaborating with cross-functional teams to ensure compliance with applicable quality systems and regulatory requirements. Essential

Responsibilities:
• Execute validation and qualification activities for equipment, processes, test methods, and manufacturing systems.
• Develop, review, and execute validation protocols, including:
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Process Characterization Studies
• Test Method Validation (TMV)
• Inspection Method Validation (IMV)
• Design of Experiments (DOE)
• Prepare, review, and maintain validation protocols, reports, and other technical documentation.
• Utilize Minitab to perform statistical analyses, process capability studies, data trending, and DOE evaluations.
• Support investigations, nonconformance assessments, corrective and preventive actions (CAPAs), and process improvement initiatives.
• Analyze manufacturing and quality data to identify trends, assess process performance, and recommend improvements.
• Collaborate with Engineering, Quality, Manufacturing, and Operations teams to support project execution and technical objectives
• Ensure compliance with applicable quality system procedures, industry standards, and regulatory requirements ​​​​​​​Minimum

Qualifications:
• Bachelor's Degree in Engineering Required.
• 2–3 years of relevant experience in engineering, validation, quality, manufacturing, or a related technical field.
• Experience in a regulated manufacturing environment, such as Medical Device, Pharmaceutical, or Biotechnology.
• 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