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Engineering Jobs in Plymouth, MN

QA Validation Engineer

Katalyst Healthcares & Life Sciences
  • Plymouth, MN
  • Instant Apply
18 days ago

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.

Numbers & Facts

LocationPlymouth, MN

Skills

  • Continuous Improvementunmatched
  • Corrective Actionunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Data Analysisunmatched
  • Documentationunmatched
  • Documentation Reviewunmatched
  • FDA Requirementsunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • Healthcare Qualityunmatched
  • ISO (International Organization for Standardization)unmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Manufacturing/Industrial Processesunmatched
  • Medical Equipmentunmatched
  • Problem Solving Skillsunmatched
  • Process Validationunmatched
  • Quality Assuranceunmatched
  • Quality Assurance Methodologyunmatched
  • Quality Engineeringunmatched
  • Quality Managementunmatched
  • Quality Metricsunmatched
  • Record Keepingunmatched
  • Regulationsunmatched
  • Regulatory Complianceunmatched
  • Regulatory Requirementsunmatched
  • Risk Analysisunmatched
  • Root Cause Analysisunmatched
  • Test Plan/Scheduleunmatched
  • Validation Documentationunmatched
  • Validation Planunmatched
  • Validation Testingunmatched

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