Medical Device 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

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