CAPA Remediation Engineer

Technical/Functional Skills
• Strong working knowledge of Medical Device Quality Management Systems (QMS) and regulatory requirements including FDA 21 CFR Part 820, ISO 13485, risk management, CAPA, change control, document control, and validation processes.
• Experience in CAPA investigation, remediation, implementation, and effectiveness verification (VoE) activities in a regulated medical device environment.
• Hands-on experience with Spreadsheet Validation, Computer System Validation (CSV), software validation, and validation lifecycle documentation.
• Ability to perform risk assessments, impact assessments, gap analyses, and root cause investigations using quality tools such as Fishbone, 5-Why, FMEA, and risk-based decision-making methodologies.
• Experience in creation and review of Validation Plans, Validation Reports, Traceability Matrices, Risk Assessment Reports, and Quality Records.
• Strong understanding of change management and document control processes, including controlled document updates, routing, approval workflows, and implementation.
• Experience supporting quality system compliance with internal procedures and global standards for spreadsheet and software validation activities identified in CAPA remediation efforts.
• Proficiency in Microsoft Office applications, particularly Advanced Excel, including formula review, data analysis, spreadsheet controls, cell protection, and audit trail documentation.
• Experience working with electronic QMS platforms such as Greenlight Guru, or equivalent document management systems.
• Ability to analyze quality data, prepare status dashboards, track actions, and generate management reports.
• Strong stakeholder management, communication, and project coordination skills in a cross-functional and global environment.
• Knowledge of manufacturing, quality assurance, supplier quality, process validation, and regulatory compliance within the medical device industry.
Experience Required 4 - 6 years
Roles & Responsibilities
• Review spreadsheet inventories and perform assessments to determine validation requirements in accordance with applicable procedures and quality standards.
• Develop and maintain spreadsheet validation documentation, including Validation Plans, Validation Reports, Risk Assessments, Validation Traceability, and Impact Assessments.
• Verify spreadsheet controls, formula integrity, access restrictions, document control requirements, and compliance with approved validation procedures.
• Support closure of CAPA corrective actions related to spreadsheet remediation and validation activities identified in the implementation plan.
• Assist in aligning local procedures with global requirements, including updates to software and spreadsheet validation processes and change control procedures.
• Prepare, review, and update-controlled quality documents, SOPs, forms, templates, work instructions, and supporting records.
• Conduct gap assessments and impact analyses to identify compliance issues and recommend corrective actions.
• Coordinate with Quality, Engineering, Manufacturing, Regulatory Affairs, and Document Control teams to obtain reviews, approvals, and timely closure of action items.
• Track project milestones, deliverables, risks, issues, and dependencies; provide regular status updates to project leadership.
• Support preparation of CAPA implementation evidence and maintain audit-ready documentation packages.
• Assist in developing Verification of Effectiveness (VoE) plans, sampling strategies, record reviews, and effectiveness evidence packages supporting long-term CAPA closure requirements.
• Participate in internal audits, compliance assessments, management reviews, and remediation activities as required.
• Support continuous improvement initiatives to strengthen quality system processes, validation compliance, and regulatory readiness.
• Ensure all deliverables are completed in accordance with applicable Zimmer Biomet procedures, quality requirements, and project timelines.

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