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.
- nalyze 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
- dvanced 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.
