Quality Systems & Validation Engineer

• 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.