A Director of Quality Assurance oversees and directs the overall operations of quality assurance within a company to ensure continuous improvement and compliance.
Who we are: NeuroSync is a pioneering neurotechnology company that delivers a cutting-edge digital health platform for objective brain health assessments and performance optimization. Trusted by leading medical centers, military, and sports organizations, our mission is to revolutionize brain health care.
Key Responsibilities:
Lead Quality and Regulatory areas as part of the leadership team. Oversee quality and regulatory activities for Class II devices/
SaMD:
registration/listing, UDI/GUDID, and change control. Serve as primary liaison for FDA submissions and interactions. Maintain QMS compliance (ISO 13485, QMSR) and ensure audit/inspection readiness. Partner with Engineering and Clinical departments on product development - risk management, usability, SaMD lifecycle, cybersecurity, and technical files.
Oversee post-market surveillance:
complaints, performance monitoring, and continuous improvement.
Ensure manufacturing and release quality:
inspections, DHRs, equipment, and validation support. Lead audits and inspections, compliance metrics and Management Review inputs, while guiding cross-functional teams.
Skills & Qualifications:
5+ years minimum in medical device Regulatory Affairs and Quality with health tech experience in the U.S. Class II or III experience. Proven work on 510(k) submissions, maintenance/changes (letters-to-file), registration/listing, UDI/GUDID, and running CAPA and post market complaints Working knowledge of
ISO 13485, ISO 14971, IEC
62304 and
IEC 62366
Excellent technical writing, organization, and cross-functional communication; able to operate as the day-to-day RA/QA lead. Experience with software/hardware (SaMD) combinations is beneficial. Bachelor's degree, ideally in engineering, life sciences, or related field, required. Master's degree preferred.
Compensation:
$160,000-$180,000 including bonus plus equity
Pay:
$160,000.00 - $180,000.00 per year
Benefits:
401(k) Dental insurance Health insurance Life insurance Paid time off Vision insurance
