Software Quality Specialist
NPAworldwide · Houston, TX · 5 mo ago
Quality Assurance$100k/yrFull-time
What You'll Be Doing
- Lead software quality activities across the full product development lifecycle.
- Own software risk management and design control documentation.
- Ensure compliance with IEC 62304, ISO 13485, FDA 21 CFR Part 820, and related regulatory standards.
- Chair change control activities for software defects, enhancements, and product updates.
- Provide technical feedback during code reviews and software/firmware investigations.
- Serve as a subject matter expert during regulatory inspections and audits.
- Partner cross-functionally with Engineering, R&D, Clinical, Regulatory, and Operations teams.
What We're Looking For
- Experience working in regulated product development environments.
- Strong communication skills with the ability to work across technical and non-technical teams.
- Bachelors degree in Computer Science, Engineering, or a related field.
- Experience with implantable or Class III medical devices is a strong plus.
Qualifications
- 6+ years of experience in software or firmware quality within the medical device industry.
- Strong knowledge of:
- IEC 62304
- ISO 13485
- FDA 21 CFR Part 820