Lead Engineer (Design Quality Assurance)
Core
Lead Design Quality Assurance Engineer ensuring on-market quality assurance support for design control activities in medical device manufacturing.
Role type
Senior IC Quality Assurance Engineer (Design Control)
Builds
Design control documentation, verification/validation plans, and product assurance plans for Point of Care diagnostics.
Domain
Medical Devices / Diagnostics / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design Control, FDA QSR compliance, GMP, ISO standards, statistical analysis, FMEA, DMF/DMR/MVP review, process validation, test method verification
Preferred skills
Process Validation, ASQ/SRE membership, competitor product analysis, electronic equipment inspection methods, leadership under pressure
Technologies
FDA QSR, GMP, ISO, FMEA, DMF, DMR, MVP
Responsibilities
Define document requirements for product and process verification/validation; guide multi-disciplinary personnel on quality standards; review and approve Design Control elements including Device History Files and Change Control; analyze data to drive decisions and recommendations; implement design control policies and procedures.
Seniority
Senior, hands-on IC
