Technical Lead

• 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., * 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.

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.