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:

• Bachelor's degree in Engineering (Software, Computer Science, or Electrical) with 5+ years of experience
• or Graduate degree with 3+ years of experience
• Relevant certifications such as ASQ CQE, CQM, or CQA preferred
• Experience working in regulated industries (e.g., Medical Devices, Aerospace)
• Strong understanding of GxP requirements and applicable standards
• Experience with embedded software, ATE, data management, or product connectivity
• Proficient in system development methodologies and software metrics
• In-depth experience in software quality engineering practices and compliance processes
• Knowledge of ISO 13485, 21 CFR Part 820, Part 11, ISO 14971, IEC 62366
• Familiarity with configuration management, change control, testing (V&V), and issue tracking
• Understanding of cybersecurity and data integrity requirements
• Experience in managing projects and leading cross-functional teams
• Risk mitigation and failure investigation experience
• Skilled in troubleshooting and root cause analysis
• Clear communicator with strong writing and presentation skills
• Knowledge of embedded software or cloud SaaS applications
• Strong leadership in driving SDLC and validation with cross-functional teams
• Ability to manage consultants, vendors, and external partners
• Excellent written and verbal communication skills
• Proven ability to work independently and collaboratively
• Competency in project management and change management practices