QA Validation Engineer

Katalyst-Healthcares-; Plymouth (MN); On-site; USD 80,000 - 110,000; Full time

Job summary

Katalyst-Healthcares- is seeking a QA Validation Engineer to support quality assurance, process validation, and test method validation in a regulated medical device environment. The candidate will apply PQ and method validation expertise and work with CAPA processes to maintain compliance.

The role requires hands-on experience in validation activities, strong knowledge of FDA regulations, GMP, and ISO 13485, and collaboration across QA, Manufacturing, Engineering, and Regulatory teams.

Qualifications

• Hands-on experience with process validation and PQ in a regulated manufacturing environment.
• Experience with Method Validation or Test Method Validation, including protocol execution and data analysis.
• Experience with CAPA, deviation management, and nonconformance investigations.
• Knowledge of FDA regulations, GMP, ISO 13485, and quality management systems.

Responsibilities

• Perform and support process validation activities, including PQ, to ensure manufacturing processes meet 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 and reproducible.
• Review validation data, analyze results, and verify compliance with acceptance criteria.
• Investigate nonconformances, product complaints, deviations, and manufacturing quality issues.
• Perform Root Cause Analysis (RCA) and support CAPA implementation and effectiveness verification.
• Maintain quality records and validation documentation in accordance with regulatory and company requirements.
• Identify quality risks and assess compliance gaps to recommend corrective measures.
• Collaborate with QA, Manufacturing, Engineering, and Regulatory teams to resolve validation issues.
• Ensure compliance with FDA regulations, GMP, ISO 13485 and applicable medical device standards.
• Support continuous improvement initiatives to enhance process performance and product quality.
• Participate in quality audits, documentation reviews, and validation-related compliance activities.

Skills

Process validation

Performance Qualification (PQ)

Method Validation

CAPA

FDA regulations

GMP

ISO 13485

Education

Bachelor's degree in engineering or related field

Job description

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.