Medical Device Quality / Validation Engineer

Medical Device Quality / Validation Engineer – CAPA & Spreadsheet Validation Remote | 6 Months Contract We are looking for a Quality/Validation Engineer with strong experience in Medical Device QMS, CAPA remediation, spreadsheet validation, and Computer System Validation (CSV). Key Responsibilities: Perform spreadsheet inventories and validation assessments Develop Validation Plans, Reports, Risk Assessments & Traceability Matrices Validate spreadsheet controls, formulas, access restrictions & audit trails Support CAPA remediation and Verification of Effectiveness (VoE) Conduct gap assessments, impact assessments and root-cause investigations Update SOPs, forms, templates, work instructions and quality records Support change control and document control activities Coordinate with Quality, Engineering, Manufacturing, Regulatory & Document Control Track project milestones, risks, issues and remediation actions Maintain audit-ready documentation and CAPA evidence packages Required Skills: Medical Device QMS FDA 21 CFR Part 820 / ISO 13485 CAPA, Change Control & Document Control Spreadsheet Validation / CSV / Software Validation Risk Assessment, FMEA, Fishbone, 5-Why Validation lifecycle documentation Advanced Excel – formulas, controls, data analysis, cell protection eQMS such as Greenlight Guru or equivalent Quality/regulatory compliance in medical devices Strong stakeholder and project coordination skills Preferred: Medical device / Orthopedic industry experience Manufacturing, Supplier Quality, Process Validation experience Experience with CAPA remediation programs Education: B.S. from an ABET-accredited school or global equivalent in: Mechanical Engineering Mechanical Engineering Technology Biomedical Engineering / Bioengineering Biomedical Engineering Technology Bioengineering Technology Aerospace Engineering Aeronautical Engineering Experience: 4–6 years 📩 Interested candidates can share their updated resumes to efrayam.sangati@camelotis.com