Engineer IV/Complaint Analysts
Core
Analyze and investigate customer complaints and returned medical devices to ensure quality, safety, and regulatory compliance.
Role type
Senior IC medical device engineer (complaints & quality)
Builds
Design control deliverables, risk management evaluations, and complaint investigation reports
Domain
Medical devices / Quality Management Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
root cause analysis, risk management, design verification, regulatory compliance, technical writing, laboratory evaluation, CAPA management, statistical analysis, mechanical/electrical engineering knowledge, prototype testing, mathematical modeling
Preferred skills
experience in regulated laboratory/quality environment, Computer-Aided Design tools proficiency
Responsibilities
Receive, log, and triage customer complaints and returned devices; perform laboratory evaluation of returned products; execute root cause analysis using structured problem-solving tools; document complaint handling activities in eQMS; determine complaint outcomes and support reportability assessments; initiate and support CAPA and nonconformance records; lead project technical workstreams; act as a technical SME and liaise with external partners; perform design and test activities related to the product and manufacturing process; develop statistically sound design verification protocols.
Seniority
Senior, hands-on IC with project leadership
