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# QA Validation Engineer

- **Company:** Katalyst Talent Agency
- **Location:** Minneapolis, MN, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Data Analysis, Iq/oq/pq, Model Validation
- **Published:** October 31, 2026
- **Apply:** https://www.juju.com/job/15_346b7792

## About the Role

* 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.

## Description

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.