Senior Design Quality Engineer
Core
Establish and lead quality engineering processes, building a Quality Management System (QMS) aligned with ISO 13485 and FDA QMSR for a healthcare AI company.
Role type
Senior Design Quality Engineer
Builds
Quality Management System (QMS), Design History File (DHF), complaint handling workflows, CAPA processes, and post-market surveillance systems.
Domain
Healthcare AI / Medical Device / Digital Health
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 13485 QMS implementation, Design Controls, Risk Management (ISO 14971), CAPA management, Complaint Handling, Post-Market Surveillance (PMS), FDA submission documentation, Design History File (DHF) maintenance
Preferred skills
FDA QMSR familiarity, Software as a Medical Device (SaMD) experience, Human factors validation, Cybersecurity testing, CE mark technical files
Technologies
ISO 13485, ISO 14971, FDA 510(k), EHR systems
Responsibilities
Lead design, implementation, and roll-out of an ISO 13485-compliant Quality Management System; Establish and standardize core quality procedures including document control, change management, CAPA, and nonconformance; Execute end-to-end complaint handling, root-cause investigations, and medical device reporting (MDR); Drive CAPA and Nonconformance processes with thorough root-cause analyses; Design and maintain the Post-Market Surveillance (PMS) system; Support execution and maintenance of design control activities across the product lifecycle; Assist in preparation of FDA submission documentation (e.g., 510(k)); Coordinate with R&D, Engineering, Customer Success, Ops, and Clinical teams to collect documentation and evidence.
Seniority
Senior, hands-on IC
