Quality Engineer
Core
Provide quality-assurance support for product design, procurement, and manufacturing to ensure compliance with customer and industry requirements.
Role type
Quality Engineer (Manufacturing)
Builds
Personal care and household products (diapers, wipes, detergents, etc.)
Domain
Consumer Goods / Manufacturing
Required skills
Quality testing, statistical methods, quality auditing, supplier assessment, GMP compliance, regulatory requirements, corrective and preventive action (CAPA), quality system procedures
Preferred skills
ASQ Certification (CQE), statistics, new product development, cost savings initiatives, internal and customer audits
Technologies
ISO 13485, 21 CFR Part 820, ISO 9001, GMP/QSR
Responsibilities
Supervise assigned staff performance and disciplinary actions, perform quality testing per approved procedures, review quality data for CAPA, apply statistical methods to testing and validation, lead quality system improvement and new product development teams, coordinate customer complaint resolution, act as primary QA contact for supplier assessment, lead internal and customer audits, oversee QA record control, devise or revise Quality Management System procedures, report significant issues and process improvements, prepare quality system presentations, conduct laboratory tours for visitors
Seniority
Mid-level, hands-on IC with leadership responsibilities