Quality Systems Engineer jobs in United States
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Nudge · 1 day ago

Quality Systems Engineer

positionSan Francisco
timeFull-time
remoteOnsite
seniorityEntry, Mid Level
date2+ years exp

Nudge is focused on developing advanced technology for brain interfacing to enhance people's lives. The Quality Systems Engineer will ensure product designs and processes comply with safety and performance standards, lead quality discussions in product development, and manage corrective actions and non-conformances.

BiotechnologyMedicalNeuroscience

Responsibilities

Ensure that new and existing product designs and processes meet all internal and regulatory requirements with respect to safety and performance
Partner in new product development by leading quality critical discussions, influencing key decisions, and driving necessary process changes across design controls, investigational studies, and clinical trials
Effectively manage multiple tasks and drive execution of change orders
Initiate and/or support corrective action and preventive action (CAPAs) and non-conformances, leading investigations and implementing mitigations
Represent and cultivate a culture of quality by working with interdisciplinary teams to set expectations, identify gaps, and meet a high internal bar for rigor

Qualification

Design controlsProduct/process validationRisk managementClinical Practice (GCP)FDA QMSRISO 13485ISO 14971Failure modeEffects analysis (FMEA)High integrityTechnical writing

Required

At least 2 years of industry experience
Experience with design controls, product/process validation, and risk management
A degree in an engineering or scientific discipline (e.g., biomedical engineering, electrical engineering, neuroscience) or equivalent hands-on experience
Familiarity with Good Clinical Practice (GCP) and human factors
Familiarity with the FDA QMSR, ISO 13485, and ISO 14971
Experience conducting risk management activities using tools such as failure mode and effects analysis (FMEA)
Strong technical writing skills
High integrity

Company

Nudge

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Nudge develops brain interface technology that helps to treat neurological problems.
dateFounded in 2024
location
San Francisco, California, USA
people-size11-50 employees
web-link
https://nudge.com

Funding

Current Stage
Early Stage
Total Funding
$100M
Key Investors
Greenoaks,Thrive Capital
2025-07-22Series A· $100M

Leadership Team

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Jeremy Barenholtz
Cofounder, President & CTO
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Recent News

BRIDGE
Investment in Next-Generation Credit Card “Nudge” Now Available through Individual Stock Fund “eCrowd NEXT” Starting on the 24th
2025-10-17
Company data provided by crunchbase