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 Include
- 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 Include
- 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
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