Job Description

Summary We are seeking a Quality Engineer II to support validation, qualification, quality assurance, and continuous improvement activities within a regulated manufacturing environment. The ideal candidate will have hands-on experience in IQ/OQ/PQ, Process Characterization, Test Method Validation (TMV), Inspection Method Validation (IMV), Design of Experiments (DOE), and statistical analysis using Minitab . This position requires strong technical documentation skills, analytical capabilities, and the ability to collaborate effectively with cross-functional teams while ensuring compliance with applicable quality and regulatory standards. Key Responsibilities Develop, execute, and support validation and qualification activities for manufacturing processes, equipment, test methods, and systems. Prepare, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. Support Process Characterization Studies, Test Method Validation (TMV), and Inspection Method Validation (IMV). Develop and execute Design of Experiments (DOE) to evaluate process performance and identify improvement opportunities. Utilize Minitab to perform statistical analysis, process capability studies, data trending, and interpretation of validation results. Generate, review, and maintain validation protocols, technical reports, and quality documentation. Support quality investigations, nonconformance evaluations, root cause analysis, and corrective actions. Analyze manufacturing and quality data to identify trends, potential risks, and opportunities for process optimization. Collaborate with Quality, Manufacturing, Engineering, and Operations teams to support project objectives. Ensure compliance with established quality systems, regulatory requirements, and internal procedures. Requirements Education Bachelor's Degree in Engineering from an accredited institution. Experience 2–3 years of experience in Quality Engineering, Validation, Manufacturing Engineering, or a related technical field. Experience supporting validation and qualification activities within a manufacturing environment. Required Skills Knowledge and practical experience with IQ/OQ/PQ protocol development and execution. Understanding of Process Characterization, DOE, TMV, and IMV methodologies. Proficiency in Minitab for statistical analysis and data interpretation. Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint. Strong technical writing, documentation, and analytical skills. Excellent verbal and written communication skills. Bilingual in English and Spanish (written and spoken). Ability to work collaboratively with cross-functional teams and manage assigned responsibilities effectively. Preferred Qualifications Experience in the medical device, pharmaceutical, or biotechnology industry. Knowledge of FDA regulations, Good Manufacturing Practices (GMP), and ISO 13485. Familiarity with risk management tools, including FMEA and risk assessments. Experience supporting investigations, nonconformances, and continuous improvement initiatives. Working knowledge of Microsoft Project.