Quality Engineer II- Medical Devices
Core
Ensure product quality and process compliance for medical device manufacturing operations through engineering principles and quality tools.
Role type
Quality Engineer II (Medical Devices)
Builds
Robust quality systems and compliant manufacturing processes for medical devices
Domain
Medical Devices / Manufacturing
Required skills
Root cause analysis, Statistical process control (SPC), Measurement systems analysis (MSA), Quality management systems (ISO 13485, ISO 9001, IATF 16949), Design reviews, Supplier quality audits, Internal/external audits, Data analysis, CAPA implementation
Preferred skills
Six Sigma Green Belt, Supplier Quality experience
Technologies
Microsoft Office Suite, Technical drawings
Responsibilities
Develop and maintain quality control plans, Conduct root cause analysis and implement CAPA, Perform statistical analysis of data, Participate in design reviews, Support supplier quality activities, Lead internal and external audits, Collaborate with cross-functional teams, Train junior quality personnel, Develop MSA studies, Prepare quality performance reports
Seniority
Mid-level, hands-on IC