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CSV Validation Engineer

Katalyst Healthcares & Life Sciences
  • Boston, MA
  • Instant Apply
5 days ago

Job Description

Job Summary
We are seeking a Medical Device Quality / CSV Validation Engineer to support quality system compliance, CAPA remediation, spreadsheet validation, and computer system/software validation activities within a regulated medical device environment. The ideal candidate will have strong knowledge of FDA 21 CFR Part 820, ISO 13485, risk

Roles & Responsibilities
  • Review spreadsheet inventories and assess validation requirements based on applicable procedures, risk, and quality standards.
  • Perform spreadsheet validation activities, including verification of formulas, calculations, data integrity, access restrictions, cell protection, controls, and audit trails.
  • Support Computer System Validation (CSV) and software validation activities throughout the validation lifecycle.
  • Support CAPA remediation activities, including corrective action implementation, documentation, and closure.
  • Develop and support Verification of Effectiveness (VoE) plans, sampling strategies, record reviews, and effectiveness evidence packages.
  • Conduct risk assessments, gap assessments, impact analyses, and root cause investigations using tools such as Fishbone, 5-Why, FMEA, and risk-based decision-making methodologies.
  • Review and update SOPs, forms, templates, work instructions, controlled documents, and other quality system records.
  • Support alignment of local procedures with global quality and validation requirements.
  • Manage document control activities, including document revisions, routing, approvals, implementation, and archival requirements.
  • Coordinate with Quality, Engineering, Manufacturing, Regulatory Affairs, Supplier Quality, and Document Control teams to obtain reviews, approvals, and timely closure of action items.
  • Track project milestones, deliverables, risks, issues, dependencies, and CAPA-related actions; provide regular status reports to project leadership.
  • Prepare and maintain audit-ready documentation packages and CAPA implementation evidence.
  • Analyze quality data and prepare dashboards, metrics, management reports, and project status updates.
  • Participate in internal audits, compliance assessments, management reviews, remediation activities, and regulatory readiness initiatives.
  • Support continuous improvement initiatives focused on strengthening QMS processes, validation compliance, and overall quality system effectiveness.
  • Ensure all deliverables are completed in accordance with applicable Client Biomet procedures, quality requirements, regulatory expectations, and project timelines.
Education & Experience
  • Minimum bachelor's degree from an ABET-accredited institution or global equivalent in one of the following disciplines: Mechanical Engineering Technology Biomedical Engineering, Biomedical Engineering Technology
  • Advanced education or relevant certifications in Quality, Validation, Regulatory Affairs, or Computer System Validation is a plus.
  • 4 6 years of relevant professional experience in medical device quality, CSV, software validation, spreadsheet validation, quality engineering, or a related regulated industry.
  • Hands-on experience with Medical Device Quality Management Systems (QMS) and regulatory requirements, including FDA 21 CFR Part 820 and ISO 13485.
  • Experience with CAPA investigation, remediation, implementation, and Verification of Effectiveness (VoE) in a regulated medical device environment.

Numbers & Facts

LocationBoston, MA

Skills

  • ABET (Accreditation Board for Engineering and Technology)unmatched
  • Biomedical Engineeringunmatched
  • Code of Federal Regulationsunmatched
  • Computer Systemsunmatched
  • Continuous Improvementunmatched
  • Corrective Actionunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Data Analysisunmatched
  • Data Qualityunmatched
  • Document Controlunmatched
  • Document Managementunmatched
  • Documentationunmatched
  • FDA (Food and Drug Administration)unmatched
  • FDA Requirementsunmatched
  • Failure Mode and Effects Analysis (FMEA)unmatched
  • Healthcare Qualityunmatched
  • Healthcare Softwareunmatched
  • ISO (International Organization for Standardization)unmatched
  • Internal Auditunmatched
  • Leadershipunmatched
  • Manufacturing Requirementsunmatched
  • Mechanical Engineeringunmatched
  • Medical Equipmentunmatched
  • Metricsunmatched
  • Process Validationunmatched
  • Project Trackingunmatched
  • Quality Controlunmatched
  • Quality Engineeringunmatched
  • Quality Managementunmatched
  • Quality Metricsunmatched
  • Regulationsunmatched
  • Regulatory Requirementsunmatched
  • Reporting Dashboardsunmatched
  • Requirements Managementunmatched
  • Requirements Validation/Verificationunmatched
  • Riskunmatched
  • Risk Analysisunmatched
  • Root Cause Analysisunmatched
  • Software Validationunmatched
  • Spreadsheetsunmatched
  • Standard Operating Procedures (SOP)unmatched
  • Status Reportsunmatched
  • System Validationunmatched
  • Systems Engineeringunmatched
  • Time Managementunmatched

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