Found Description
Responsibilities
- Establish and maintain software quality assurance processes and controls for FDA and IEC 62304 compliance
- Act as a Quality partner across Product, Engineering, and SQE teams
- Support design and development lifecycle deliverables including DHF, MDF, and traceability matrices
- Lead risk management lifecycle activities and maintain Hazard Analyses per ISO 14971
- Own CAPA investigations from root cause to resolution
- Support implementation and improvement of eQMS tools and AI-enabled solutions
- Manage eQMS tool administration, including document routing and approvals
- Support internal and external audits, including FDA inspections
- Support verification, validation, and electrical safety/EMC testing
- Investigate and resolve complaint-related software issues
Requirements
- Bachelor’s Degree in Electrical Engineering, Computer Engineering, or related technica...