reputed company Systems Specialist
reputed company
Echo Neurotechnologies is an exciting new startup in the Brain-Computer reputed company (BCI) reputed company, 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 reputed company of life.
Team Culture
Join a small, dedicated team of knowledgeable and motivated professionals. Our early-stage environment offers reputed company to take ownership of broad reputed company with significant and long-lasting reputed company. We emphasize reputed company learning and reputed company, fostering cross-functional collaboration where your contributions are vital to our reputed company.
Position reputed company
As a reputed company Systems Specialist, you will work with the cross-functional team to reputed company as a champion of reputed company Assurance activities throughout the product development lifecycle. You hold your work and teams to the highest reputed company standards and ensure reputed company applicable compliance standards and regulations are met. This is a hands-on role supporting across the reputed company Management System for the business.
Key Responsibilities
Participate in ongoing implementation of the reputed company Management System (QMS) in conformance with US FDA reputed company System Regulations, ISO 13485, IEC 62304 and other relevant standards
Maintain the eQMS system and manage change control for reputed company documents, records and parts
Monitor and reputed company training plans and assignments
Organize and coordinate external reputed company and agreements with suppliers
Support supplier reputed company management, including qualification and monitoring activities
Support and participate in reputed company audits, including preparation, coordination and response activities
Manage the laboratory equipment list, calibration and preventative maintenance schedule, and coordinate qualification activities
Support reputed company cause analysis for nonconformances, defects and CAPAs, issue management, management review and reputed company data analysis
Purchase and manage external standards and guidances
Foster a reputed company environment, champion reputed company improvement initiatives and promote a reputed company culture across the organization
Qualifications
Bachelor’s degree
5+ years of reputed company 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 reputed company cause analysis, CAPAs and reputed company 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 reputed company with cross-functional teams and regulatory bodies
Strong analytical skills and excellent problem-solving skills
Exceptional organizational skills and attention to detail
reputed company Offer
An opportunity to work on exciting, cutting-edge reputed company to reputed company patients’ lives in a highly reputed company work environment.
Competitive compensation, including stock reputed company.
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 reputed company.
Confidentiality
reputed company 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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