BrainRobotics · 13 hours ago
Quality Assurance Engineer
Austin, TX
Full-time
Onsite
Entry Level
$60K/yr - $70K/yr
1+ years expBrainRobotics is a scale-up innovator in the prosthetics industry, dedicated to enhancing lives through cutting-edge bionic solutions. We are seeking a detail-oriented Quality Assurance Engineer to support our prosthetic technologies by ensuring compliance with global quality standards and FDA regulations.
Intelligent SystemsRobotics
Responsibilities
Assist in the development and maintenance of the QMS, including the creation and update of Standard Operating Procedures (SOPs) and Work Instructions to ensure alignment with FDA regulations
Execute technical quality procedures and validation protocols for FDA Class I medical devices, including hardware, firmware, and software applications. Assist in developing test cases to verify that prosthetic devices meet engineering specifications and user needs
Support root-cause investigations into technical issues and escalated field events; manage Corrective and Preventive Action (CAPA) activities and tracking. Monitor quality metrics and prepare data-driven reports (NCR, CAPA, supplier performance) to help leadership identify areas for process improvement
Perform incoming inspections, MRB activities, and Device History Record (DHR) reviews. Manage Engineering Change Orders (ECO/DCO) process to ensure technical changes are documented and approved
Partner with R&D, manufacturing and quality teams to ensure all product updates and new releases meet strict performance and documentation criteria prior to launch, while performing additional duties as assigned by management to support departmental goals
Qualification
Required
Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, or a related technical field from an ABET-accredited program
1–2 years of hands-on experience in quality engineering or quality assurance within the medical device industry (Class I or II preferred)
Strong understanding of FDA 21 CFR Part 820, ISO 13485, and QMSR
Familiarity with hardware/software validation and risk management reports
Excellent written and verbal skills, with the ability to document technical work clearly and influence cross-functional teams
Proven ability to juggle multiple priorities and release deadlines in a fast-paced environment without compromising safety or quality
Preferred
ASQ (CQE/CQT) or Six Sigma Green Belt certification
Working knowledge of prosthetic/orthotic devices or clinical vocabulary
Familiarity with CI/CD practices for firmware/software testing and Agile/Scrum frameworks
Previous experience in a startup or high-growth 'scale-up' environment
Company
BrainRobotics
BrainRobotics aims to provide an lutionafforadable sollution for arm amputees.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$0.05M2016-11-03Grant· $0.05M
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