Software Quality Engineer

Drive Innovation in Pharma Software Quality

Keep the heartbeat of innovation running and ensure cutting-edge pharma never misses a beat. Contribute to the development and maintenance of technical documentation while ensuring compliance with global regulatory and quality standards for Software as a Medical Device (SaMD) products, including AI-enabled software. Collaborate with cross-functional teams to support software lifecycle processes, risk management, and audit readiness.

Core Responsibilities

• Support and improve software lifecycle processes in compliance with IEC 62304, ISO 13485, and other regulatory requirements.
• Participate in design reviews, verification/validation activities, risk assessments, and release readiness reviews.
• Assist in software risk management, including hazard analysis and traceability of risk controls.
• Maintain software configuration and change management records for compliance and audit readiness.
• Contribute to cybersecurity and Software of Unknown Provenance (SOUP) documentation activities.
• Author, update, and maintain technical documentation, including design inputs/outputs and traceability matrices.
• Ensure documentation aligns with regulatory expectations and approved design changes.
• Establish and maintain end-to-end traceability across requirements, design, risk, implementation, testing, and release.
• Develop and track documentation plans and timelines aligned with product milestones.
• Support design and documentation reviews, ensuring outcomes are captured and reflected in technical documentation.
• Facilitate audit and inspection readiness by organizing documentation and ensuring traceability.
• Support investigations related to software defects, customer complaints, CAPAs, and post-market feedback.
• Track and manage quality actions, ensuring timely updates to procedures and documentation.

Key Skills and Requirements

• Background in systems engineering, software, or a related field.
• Familiarity with ISO 13485, FDA 21 CFR Part 820-QMSR, IEC 62304, and ISO 14971.
• Experience authoring technical documentation for SaMD in regulated environments.
• Ability to translate complex engineering and AI-ML concepts into clear, structured documentation.
• Strong technical writing skills with attention to detail and version control.
• Proven ability to manage documentation across multiple stakeholders and meet tight deadlines.
• Excellent organizational, coordination, and communication skills.
• Flexibility in working style and problem-solving approach.