Validation Engineer

Roles & Responsibilities :

• Software quality assurance or software validation.
• Preferably within the medical device industry.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, IEC 62304.
• Experience in non-product software validation.
• Includes tools for development, testing, maintenance.
• Deep understanding of quality standards and regulatory requirements :
• FDA 21 CFR Part 820.
• ISO 13485.
• IEC 62304.
• Software quality assurance.
• Software validation.
• Non-product software tools (for testing, dev, maintenance.)
• Strong multitasking and prioritization.
• Interpret and respond to regulatory & customer requirements quickly.
• Work in teams and solve problems independently.
• Validation Responsibilities :
• Plan, schedule, organize validation for new and existing applications from :
• Manufacturing.
• Quality Control.
• Clinical.
• R&D departments.
• Draft, review & approve.
• User Requirements (URS), Functional Specifications, Design Specs.
• Configuration Specs.
• Deviation and non-conformance reports.
• SOPs related to QMS.
• Prepare & review audit trails, risk assessments, GxP applicability.
• uthor Validation Plans & Summary Reports.
• Perform traceability matrix creation.
• Cross-Department Interaction.
• Interact with stakeholders for cooperation and validation approvals.
• Work closely with Quality and Compliance teams.
• Participate in audits - internal, vendor, and regulatory.
• Regulatory Alignment.
• Ensure compliance with internal SOPs, forms, and Periodic Review procedures.
• Conduct QMS and regulatory training.