Quality Systems Specialist

Company Overview

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.

Team Culture

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.

Position Overview

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.

Key Responsibilities

• 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

Qualifications

• 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

Skills and Abilities

• 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

What We Offer

• 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.

Equal Opportunity Employer

Echo Neurotechnologies is an Equal Opportunity Employer (EOE). We celebrate diversity and are committed to creating an inclusive environment for all employees.

Confidentiality

All applications will be treated confidentially. Applicants may be asked to sign an NDA after the initial stages of the interview process.