CSV Validation Engineer

Job-ID33196738Reference26-01934 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.