Technical Lead Los Angeles, California Job Summary Maintain and improve the Software Quality Management System (QMS) in compliance with organizational and regulatory requirements. Develop, review, update, and maintain Quality Management System (QMS) procedures, work instructions, templates, and related documentation. Create and manage technical and regulatory documentation to support software quality and compliance activities. Drive risk management, cybersecurity, verification, validation, and design control activities. Experience working in Agile/Scrum environments and knowledge of SDLC methodologies Maintain compliance with

FDA, ISO 13485, IEC 62304, ISO

14971, and other regulatory requirements. Collaborate with cross-functional teams to improve product quality, reliability, and patient safety. Key Responsibilities Manage and control key software quality documents, work instructions and process documents, including: Software Requirements Management (SRS and Requirements Procedures) Software Verification & Validation (V&V) Work Instructions Software Configuration Management Plans and Work Instructions Software Change Control Procedures and Records Software Release and Distribution Control Procedures Software Project Planning and Software Acquisition Procedures Software Development Documentation Standards and Design Review Processes Software Investigation, Problem Resolution, Design Transfer, Installation, and Deployment Procedures Create and maintain software engineering guidance documentation, including: Software Design Guidelines Design-Based Testing Guidelines Stress Testing Guidelines Verification Test Execution Guidelines Test Execution and User Training Documentation Create and maintain software process templates, including: Software Interaction Analysis Template Software Impact Analysis Checklist Change Assessment Templates for Creating and Supporting Software Requirements, Verification, and Review Templates Software Quality Records and Compliance Checklists Lead quality engineering activities, including risk assessments (RMF, FMEA, Cybersecurity) and quality plan execution. Manage CAPA investigations, root cause analysis, corrective actions, and effectiveness monitoring. Review and approve requirements, design documents, test protocols, test results, and change requests. Support software change management, product recertification, DHF compliance, and audit activities. Drive continuous improvement initiatives while ensuring compliance with

QMS, FDA

regulations, and industry standards.

Skill Requirements Required Qualifications:

2 to 5 years of experience Bachelor's degree in computer science, Software Engineering, Biomedical Engineering, or related field. Experience in QMS procedure development and technical/regulatory documentation. Strong knowledge of SDLC, software quality, and quality management systems. Experience in regulated industries such as Medical Devices, Healthcare, or Pharmaceuticals. Other Requirements Maximum Salary (US): 128000 Minimum Salary (US): 69000