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

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