Design (Software) Quality Engineers

Job Summary

We are seeking a Software Quality Assurance (SQA) Engineer to support software quality activities for medical device products. The ideal candidate will have experience working in regulated environments and a strong understanding of software validation, quality systems, and regulatory requirements such as FDA 21 CFR Part 820, ISO 13485, and IEC 62304.

Key Responsibilities

• Support Software Quality Assurance activities throughout the software development lifecycle.
• Review and approve software requirements, design documents, test protocols, and validation reports.
• Ensure software development processes comply with FDA, ISO 13485, IEC 62304, and company quality standards.
• Participate in software risk management activities in accordance with ISO 14971.
• Conduct software quality audits and process assessments.
• Review software verification and validation (V&V) documentation.
• Support design control activities, including requirements traceability and change management.
• Collaborate with R&D, Regulatory Affairs, Manufacturing, and Quality teams.
• Assist with CAPA, nonconformance investigations, and root cause analysis.
• Support internal and external audits and regulatory inspections.
• Maintain software quality records and ensure compliance documentation is complete and accurate.

Required Qualifications

• Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, Electrical Engineering, or related field.
• 3 years of Software Quality Assurance experience in Medical Devices, Healthcare, Pharmaceutical, or regulated industries.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, IEC 62304, and ISO 14971.
• Experience with software verification and validation activities.
• Understanding of Design Controls and Software Development Life Cycle (SDLC).
• Experience reviewing software documentation and test evidence.
• Strong analytical and problem-solving skills.
• Excellent communication and documentation skills.