12262 Quality Engineer I
Core
Coordinate supplier audits, lead root cause investigations, and ensure supplier compliance with regulatory and customer requirements in the pharmaceutical/chemical industry.
Role type
Quality Engineer I (Supplier Quality)
Builds
Supplier quality assurance processes and corrective action plans
Domain
Pharmaceutical/Chemical manufacturing and supply chain
Deliverable
client delivery
Required skills
ISO9001/ISO13485 auditing, root cause analysis (RCA), FMEA (DFMEA/PFMEA), statistical process control (SPC), Cpk analysis, DMAIC, GMP compliance, supplier management, quality documentation, SAP/eQMS tools
Preferred skills
Lean, Six Sigma Green Belt, data analytics, RCA tools
Technologies
SAP, eQMS, statistical software
Responsibilities
Coordinate and plan supplier audits, conduct ISO9001/ISO13485 audits, lead root cause investigations of nonconformities, develop and implement corrective actions, analyze supplier actions using quality tools, manage supplier quality documentation, prepare reports for management, support alternate supplier approval
Seniority
Junior to Mid-level, hands-on IC
