Software Quality Assurance Leader

We are seeking a skilled Software Quality Assurance Engineer to join our team. As a key member of our quality engineering group, you will be responsible for ensuring the quality and reliability of our software products.

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

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

As a valued member of our team, you will have the opportunity to grow and develop your career in a dynamic and supportive environment. We offer a comprehensive benefits package, including medical, dental, and vision insurance, as well as 401(k) matching and paid time off.