QA Validation Engineer

Job-ID Reference
26-02050

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.