Quality Control Representative - 1st Shift
Core
Perform first piece inspections, line audits, non-conforming product holds, and statistical sampling to assure manufacturing operations meet quality system and product requirements.
Role type
Quality Control Representative
Builds
Medical device manufacturing operations
Domain
Medical Technology / Manufacturing
Required skills
Statistical sampling (ANSI Z1.4), GMP compliance, inspection equipment operation (optical comparator, smartscope), SAP system usage, documentation control, defect management, continuous improvement (Kaizens), visual instruction development
Preferred skills
Product and process specification interpretation, drawing interpretation, process control tools knowledge, Quality System Regulations (QSR) fundamentals, ISO standards knowledge, Six Sigma, machine and process capability studies
Technologies
SAP, Excel, Word, PowerPoint, Optical Comparator, Smart-Scope, Instron
Responsibilities
Conduct line audits to assure compliance to the quality system, Perform first piece inspection of molded parts, Trend quality metrics and investigate specific problem areas, Support product complaint investigations and corrective actions, Create and update Quality Notifications, Certificates, and Global Holds in SAP, Release products for sale in SAP, Assist in validation processes and conduct machine and process capability studies, Communicate daily with prior and post shift Quality Control Representatives
Seniority
Entry-level, hands-on IC