KH
QA Validation Engineer
Katalyst Healthcares & Life Sciences
- 🇬🇧 United Kingdom | 🇺🇸 United States
- On-site
- 19 hours ago
- CAPA
- GMP
19 hours ago
Not enough detail in this posting to match
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.
- 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.
QA Validation Engineer · Katalyst Healthcares & Life Sciences