About the job
Join Nudge as a Quality Systems Engineer!
At Nudge, we're committed to revolutionizing the way we interface with the brain through innovative technology aimed at enhancing human lives. Our flagship project involves developing a groundbreaking, non-invasive ultrasound device designed to stimulate and visualize the brain with unparalleled precision. This initiative integrates advanced hardware, software, and extensive research to create impactful products that can ultimately benefit millions, if not billions, of individuals.
To achieve our ambitious goals, we focus on building exceptional teams across all areas. We seek talented individuals who excel in their fields, embrace challenging tasks, and strive for excellence with unwavering integrity.
Your Role:
As a Quality Systems Engineer at Nudge, you will:
Guarantee that all product designs and processes adhere to internal and regulatory safety and performance standards.
Collaborate in new product development, steering quality discussions, influencing critical decisions, and implementing process changes related to design controls, investigational studies, and clinical trials.
Manage multiple tasks effectively while driving the execution of change orders.
Lead investigations and implement corrective and preventive actions (CAPAs) alongside addressing non-conformances.
Foster a quality-driven culture by partnering with interdisciplinary teams to set quality expectations, identify gaps, and uphold high internal standards.
About You:
We are seeking candidates for the Quality Systems Engineer position who possess a minimum of 2 years of relevant industry experience. Key qualifications include:
Proficiency in design controls, product/process validation, and risk management.
A degree in an engineering or scientific field (e.g., biomedical engineering, electrical engineering, neuroscience) or equivalent practical experience.
Understanding of Good Clinical Practice (GCP) and human factors.
Familiarity with FDA QMSR, ISO 13485, and ISO 14971 standards.

