Senior Quality Engineer
Core
Senior Supplier Quality Engineer driving continuous process improvement, compliance, and risk management for IVD medical devices and diagnostics.
Role type
Senior IC quality engineer (medical devices/IVD)
Builds
Process control systems, quality plans, risk assessments, and validated manufacturing processes for diagnostic instruments.
Domain
Healthcare diagnostics / Medical Devices / IVD
Required skills
Root cause analysis, CAPA, FMEA, Lean Six Sigma, QMS compliance, regulatory standards (ISO/FDA), cross-functional collaboration, project management, process audits, design control support.
Preferred skills
IVD/medical device manufacturing experience, ASQ CQE certification, Lean Six Sigma Black/Green Belt, new product development, design transfer, supplier audit, reagent/ELISA/HEIA manufacturing knowledge, supervisory experience.
Technologies
QMS, ISO 13485, ISO 14971, FDA QSRs, IVDR, HACCP, GMP, GLP, GDP
Responsibilities
Conduct process audits and drive continuous improvement initiatives; Lead development and monitoring of process control systems and CTQ measures; Provide QA support for IVD device development and lifecycle management; Lead risk management activities (FMEA, failure mode analysis); Investigate and resolve product/process nonconformances; Design and execute process optimization studies; Collaborate cross-functionally with R&D, Manufacturing, and Quality teams; Champion Lean Manufacturing and Six Sigma initiatives; Ensure compliance with QMS, ISO, FDA, and company policies.
Seniority
Senior, hands-on IC with leadership/mentorship