QA Systems Engineer
Core
Execute complex validations (IQ, OQ, PQ, MSA) for processes, equipment, and computerized systems within a regulated manufacturing facility.
Role type
Quality Assurance Systems Engineer
Builds
Validated processes, equipment, and computerized systems for medical device manufacturing
Domain
Medical device manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation protocols (IQ/OQ/PQ/MSA), Change control management, Root cause analysis, Engineering principles (CAD, electrical, mechanical, chemical, industrial, biological), Technical documentation, Cross-functional collaboration
Preferred skills
Six Sigma, Lean, ASQ certification, cGMPs knowledge, Good Manufacturing Practices
Technologies
CAD, Software-based scheduling tools
Responsibilities
Support and execute complex validations with little or no guidance, Own and drive change control, Assist or lead process improvement projects, Work collaboratively with cross-functional teams, Assist in process design and equipment installation, Provide technical reports and data-driven analysis
Seniority
Mid-level IC (1-3 years experience preferred)
