QA Validation Engineer - Medical Devices PQ & Method

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

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.