CSV Validation Engineer

Katalyst-Healthcares-; Boston (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

JobDiva, Inc. in Boston is seeking a Medical Device Quality / CSV Validation Engineer to support quality system compliance, CAPA remediation, spreadsheet validation, and computer system validation activities within a regulated medical device environment.

The role requires hands-on experience with FDA 21 CFR Part 820 and ISO 13485, plus strong problem-solving skills for risk assessments, documentation, and cross-functional collaboration across Quality, Engineering, Manufacturing, Regulatory

Qualifications

• ABET‑accredited Bachelor’s degree or global equivalent in Mechanical Engineering Technology or Biomedical Engineering.
• Advanced education or certifications in Quality, Validation, Regulatory Affairs, or CSV is a plus.
• 4–6 years in medical device quality, CSV, software validation, spreadsheet validation, or related regulated industry.
• Hands‑on experience with QMS and regulatory requirements including FDA 21 CFR Part 820 and ISO 13485.

Responsibilities

• Review spreadsheet inventories and assess validation requirements per procedures, risk, and quality standards.
• Perform spreadsheet validation: verify formulas, data integrity, access restrictions, and audit trails.
• Support CSV and software validation across the validation lifecycle.
• Assist CAPA remediation including corrective action documentation and closure.
• Develop Verification of Effectiveness plans, sampling strategies, and evidence packages.
• Conduct risk assessments, gap analyses, and root cause investigations using standard methodologies.
• Update SOPs, forms, templates, and controlled documents to align with global requirements.
• Coordinate with Quality, Engineering, Manufacturing, Regulatory Affairs, and Document Control teams.
• Track milestones, risks, issues, dependencies, and CAPA actions; report status to leadership.
• Prepare audit‑ready documentation and CAPA evidence; analyze quality data for dashboards and reports.
• Participate in internal audits, compliance assessments, and regulatory readiness initiatives.
• Support continuous improvement of QMS processes and overall quality system effectiveness.
• Ensure deliverables meet Client Biomet procedures, quality requirements, regulatory expectations, and timelines.

Skills

Spreadsheet validation

CSV validation

CAPA remediation

Risk assessment

QMS knowledge

FDA 21 CFR Part 820

ISO 13485

Documentation

Cross-functional collaboration

Education

ABET-accredited Bachelor's degree in Mechanical/Biomedical Engineering/related

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.