Staff Quality Assurance Engineer

Key Responsibilities :

• Assure compliance with software procedures and guide teams on development life cycle appropriateness
• Identify task dependencies and ensure effective development and maintenance efforts
• Lead both internal and external audits for software quality systems
• Provide training on ASP software quality engineering procedures to staff, contractors, and business partners
• Lead compliance and risk management activities for software or system projects
• Improve software quality processes based on industry trends and regulatory expectations
• Ensure compliant, reliable systems prioritizing patient safety are transferred to users
• Manage software change control in alignment with quality procedures and work instructions
• Implement systems that address evolving regulations
• Represent the Software Quality Engineering function during regulatory inspections
• Recommend issue resolutions to senior management for compliance and capability concerns
• Ensure Quality System Regulations are followed, including FDA, ISO13485, IEC 62304, ISO 14971, and Sarbanes-Oxley
• Maintain documented evidence to validate that systems meet specifications and quality standards
• Recommend updates to SOPs related to Computer Systems Validation (CSV)
• Provide regulatory consulting, training, and assessments aligned with current requirements and trends
• Lead continuous improvement in Software Development Lifecycle (SDLC) management
• Convert business needs into validated, compliant solution designs
• Act as a technical SME for CSV processes and regulatory audits worldwide
• Communicate business-related issues or opportunities to next-level management
• Perform other duties as assigned

Required Qualifications :

Skills Required

Csv, Sdlc, Iso 14971, Risk Management, Embedded Systems, Quality Assurance Engineering