Design Quality Engineer
Core
Ensure effective design, development, and transfer processes adhere to FDA, EU regulations, and ISO 13485 standards for medical device software.
Role type
Design Control Specialist (Quality Engineering)
Builds
Vendor-neutral imaging software for clinical workflows
Domain
Healthcare / Medical Device Software (SaMD)
Deliverable
client delivery
Required skills
Design Control regulations expertise, Risk Management (ISO), Quality Management System (QMS) compliance, Regulatory filing documentation, CAPA management, Root-cause analysis, Audit support
Preferred skills
Software as a Medical Device (SaMD) experience, Design Engineering background, Crisis leadership
Technologies
FDA 21 CFR 820, ISO 13485, MDSAP
Responsibilities
Develop and manage design and development quality systems, Perform design project reviews, Participate in risk assessments and mitigation strategies, Support product design investigations (nonconformities, complaints), Author Design Control documentation for regulatory filings, Assist during supplier and notified body audits
Seniority
Mid-Senior, hands-on IC