- Company Name
- Hydrogen Group
- Job Title
- Sr Software Quality Engineer
- Job Description
-
**Job Title**
Senior Software Quality Engineer
**Role Summary**
Lead software quality assurance for regulatory‑compliant medical device and research‑use‑only software. Oversee design controls, risk management, Design History File administration, and best‑practice implementation to ensure adherence to IVDR, 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971. Act as SME for quality engineering, code reviews, security analysis, and audits, driving continuous improvement across development teams.
**Expectations**
- Deliver full lifecycle quality processes for both IVDR‑regulated and RUO software.
- Own and maintain risk documentation (RMFs, hazard analyses, dFMEAs).
- Ensure design history files are complete, accurate, and audit‑ready.
- Provide expert guidance on software design quality, verification, validation, and transfer.
- Lead root‑cause investigations and corrective action monitoring.
**Key Responsibilities**
1. Manage Software Design Quality: design controls, risk management, DHF ownership.
2. Support project planning, requirements, verification, validation, transfer, process development, and validation.
3. Conduct risk assessments, create/maintain RMFs, hazard analyses, dFMEAs, and risk reports.
4. Serve as SME for code reviews, software security analysis, vulnerability triage, and SBOM creation/maintenance.
5. Implement and enforce software quality best practices across teams.
6. Prepare and support audits for DHF completeness and compliance.
7. Investigate complaints and software‑related issues, initiate corrective actions, and verify effectiveness.
8. Contribute to broader Quality Management System activities as required.
**Required Skills**
- Deep knowledge of ICD regulations (IVDR, 21 CFR 820, ISO 13485, IEC 62304, ISO 14971).
- Expertise in software quality engineering for digital health and medical device data systems.
- Proficiency in risk management methodologies (hazard analysis, dFMEAs, RMFs).
- Strong analytical, investigative, and documentation abilities.
- Excellent written and verbal communication; stakeholder collaboration.
- Self‑starter who can manage competing priorities in a fast‑paced environment.
**Required Education & Certifications**
- Bachelor’s or Master’s degree in Engineering, Bioengineering, Bioinformatics, Computer Science, or related field.
- Minimum 5 years’ experience in Software Quality Engineering for medical devices, digital health, or bioinformatics.
- Certifications such as Six Sigma Green/Black Belt, or equivalent R&D quality certifications preferred.