QA Validation Engineer

Job Summary

We are seeking a qualified QA Validation Engineer to support quality assurance, process validation, and test method validation activities within a regulated medical device manufacturing environment. The ideal candidate will have hands-on experience with Process Validation, Performance Qualification (PQ), and Method Validation, along with a strong understanding of quality management systems and applicable regulatory requirements.

Roles and Responsibilities

• Perform and support process validation activities, including Performance Qualification (PQ), to ensure manufacturing processes consistently meet established requirements.
• Develop, review, execute, and maintain validation protocols, test plans, and validation reports.
• Support test method validation and verification activities to ensure testing methods are accurate, reliable, and reproducible.
• Review validation data, analyze results, and verify compliance with predefined acceptance criteria.
• Investigate nonconformances, product complaints, deviations, and manufacturing quality issues.
• Perform Root Cause Analysis (RCA) and support the implementation and effectiveness verification of Corrective and Preventive Actions (CAPA).
• Maintain accurate quality records, validation documentation, procedures, and reports in accordance with regulatory and company requirements.
• Identify quality risks, assess compliance gaps, and recommend appropriate corrective and preventive measures.
• Collaborate with Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs teams to resolve quality and validation issues.
• Ensure compliance with FDA regulations, GMP requirements, ISO 13485, and applicable medical device quality standards.
• Support continuous improvement initiatives to enhance process performance, product quality, and quality management system effectiveness.
• Participate in quality audits, documentation reviews, and validation-related compliance activities as required.

Education and Experience

• Bachelor's degree in engineering, technical discipline, or an equivalent combination of education and relevant experience.
• 2 5 years of relevant experience in Quality Assurance, Quality Engineering, Validation Engineering, or a related technical field.
• Hands-on experience with process validation and/or Performance Qualification (PQ) in a regulated manufacturing environment.
• Experience with Method Validation or Test Method Validation, including protocol execution, data analysis, and documentation.
• Working knowledge of CAPA, Root Cause Analysis, deviation management, and nonconformance investigations.
• Knowledge of FDA regulations, Good Manufacturing Practices (GMP), ISO 13485, and quality management systems.