Quality Systems Engineer

About the role

We are seeking a Quality Systems Engineer (Design Controls) to develop and enhance software-focused design control systems that ensure regulatory compliance throughout the software lifecycle.

Responsibilities

• Designing and implementing scalable systems aligned with IEC 62304 and FDA requirements
• Developing end‑to‑end traceability frameworks linking user needs, requirements, design outputs, and verification evidence
• Integrating software risk management in accordance with ISO 14971
• Building change control mechanisms supporting rapid iteration
• Embedding compliance into CI/CD pipelines and automating evidence generation
• Managing subsets of the Quality System related to software design controls, risk management, change control, and verification & validation

Qualifications

• Bachelor’s degree in Electrical Engineering, Computer Science, or related field
• Experience designing or maintaining structured engineering or compliance systems
• Familiarity with software development in regulated or safety-critical environments
• Knowledge of design controls, software requirements management, and basic scripting or automation (e.g., Python, SQL)
• Strong communication and problem-solving skills

Preferred Qualifications

• Familiarity with IEC 62304, FDA Design Controls (21 CFR 820.30), and ISO 14971 principles
• 1–3 years of experience in design controls, software quality, or regulated software development