Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting-edge technologies that restore autonomy to people living with disabilities and improve their quality of life.
Join a small, dedicated team of knowledgeable and motivated professionals. Our early-stage environment offers the opportunity to take ownership of broad decisions with significant and long-lasting impact. We emphasize continuous learning and growth, fostering cross-functional collaboration where your contributions are vital to our success.
As a Quality Systems Specialist, you will work with the cross-functional team to act as a champion of Quality Assurance activities throughout the product development lifecycle. You hold your work and teams to the highest quality standards and ensure all applicable compliance standards and regulations are met. This is a hands-on role supporting across the Quality Management System for the business.
Participate in ongoing implementation of the Quality Management System (QMS) in conformance with US FDA Quality System Regulations, ISO 13485, IEC 62304 and other relevant standards
Maintain the eQMS system and manage change control for all documents, records and parts
Monitor and deploy training plans and assignments
Organize and coordinate external contracts and agreements with suppliers
Support supplier quality management, including qualification and monitoring activities
Support and participate in internal and external audits, including preparation, coordination and response activities
Manage the laboratory equipment list, calibration and preventative maintenance schedule, and coordinate qualification activities
Support root cause analysis for nonconformances, defects and CAPAs, issue management, management review and quality data analysis
Purchase and manage external standards and guidances
Foster a collaborative environment, champion continuous improvement initiatives and promote a quality culture across the organization
Bachelor’s degree
5+ years of quality systems or medical device experience
Strong understanding of medical device regulations and standards (FDA 21 CFR Part 820, ISO 13485, IEC 62304) and experience working in a regulated environment
Experience working in eQMS environments
Experience in root cause analysis, CAPAs and quality data analysis
Experience in establishing work relationships across multi-disciplinary teams and with partners in different time zones, building trust and demonstrating critical thinking
Experience in navigating ambiguity and thriving in a fast-paced environment
Proficient in working in eQMS tools with impeccable documentation skills
Superior written and verbal communication skills to interface with cross-functional teams and regulatory bodies
Strong analytical skills and excellent problem-solving skills
Exceptional organizational skills and attention to detail
An opportunity to work on exciting, cutting-edge projects to transform patients’ lives in a highly collaborative work environment.
Competitive compensation, including stock options.
Comprehensive benefits package.
401(k) program with matching contributions.
Echo Neurotechnologies is an Equal Opportunity Employer (EOE). We celebrate diversity and are committed to creating an inclusive environment for all employees.
All applications will be treated confidentially. Applicants may be asked to sign an NDA after the initial stages of the interview process.
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