Quality Engineer (QMS)

TL;DR

Quality Engineer (QMS): Maintaining and improving compliance of the Quality Management System for an at-home EEG platform with an accent on ISO 13485 and 21 CFR Part 820 standards. Focus on supplier qualification, CAPA management, and coordinating complex internal and external audits to ensure regulatory compliance.

Location: Must be located in the US, preferably in or near Boston or New York (Remote/Hybrid).

Company

hirify.global is a leading at-home EEG platform utilizing AI algorithms and cloud-native analytics to revolutionize precision medicine for neurological, psychiatric, and sleep disorders.

What you will do

• Maintain and improve a 21 CFR Part 820 and ISO 13485 compliant QMS, including drafting and approving procedures.
• Manage supplier qualification, evaluations, audits, and the implementation of corrective actions.
• Oversee critical QMS processes including nonconformity, CAPA, deviation management, and employee training compliance.
• Ensure timely closure of deviations and maintain rigorous documentation standards.
• Coordinate and manage schedules, meetings, and reports for all internal and external audits.

Requirements

• Bachelor’s degree in Biomedical, Electrical, or Systems Engineering, or 5 years of equivalent experience in a regulated industry.
• 5+ years of quality management experience following ISO 13485:2016 and 21 CFR Part 820.
• Hands-on experience with electronic Quality Management Systems (eQMS).
• Proven track record of auditing and being audited in regulated environments.
• Ability to work autonomously with strong analytical and problem-solving skills.

Nice to have

• Certified Quality Auditor, Certified Quality Engineer, or Certified Software Quality Engineer certification.

Culture & Benefits

• Total compensation package including base salary and equity.
• Paid Time Off (PTO) and comprehensive benefits.
• Culture centered on curiosity, simplicity, and deep empathy for patients and colleagues.
• Collaborative environment that values diversity and a self-service mindset.