Nudge
Quality Systems Engineer
San Francisco · On-site · Full-time · Posted Feb 5, 2026
- Experience
- At least 2 years of industry experience.
- Education
- A degree in an engineering or scientific discipline (e.g., biomedical engineering, electrical engineering, neuroscience) or equivalent hands-on experience.
About the job
Ensures Nudge’s product designs and processes meet internal and regulatory safety and performance requirements, supporting product development and clinical activities.
What you'll do
- Lead quality-critical discussions and drive process changes across design controls, investigational studies, and clinical trials.
- Manage change orders and support CAPAs and non-conformances, including investigations and mitigations.
- Work with interdisciplinary teams to identify quality gaps and uphold rigorous standards.
What they ask for
- Experience with design controls, product/process validation, and risk management.
- Degree in an engineering or scientific discipline, or equivalent hands-on experience.
- Familiarity with Good Clinical Practice (GCP), human factors, FDA QMSR, ISO 13485, and ISO 14971.
- Risk management experience using tools such as failure mode and effects analysis (FMEA), plus strong technical writing skills.
Tools
FDA QMSR, ISO 13485, ISO 14971, FMEA, Good Clinical Practice (GCP)
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