The Quality Assurance Engineer manages site-wide ISO 9001 certification efforts by leading and facilitating audits of the quality management system. A key interface with operations, engineering, manufacturing, supply chain, logistics, customers, vendors and third party compliance partners to ensure quality management systems requirements are met. Ability to develop training materials to continually improve an ISO 9001 certified site. Evaluate risk to the organization and its customers by auditing product quality plans (PQPs), product design and development records and other QMS related documented information. Leads or assists in site-wide customer and third party compliance audits. Make recommendations for corrective actions and risk reducing measures based on trends in audit findings.
Ensures processes for products and services conform to established company, customer and regulatory requirements. Reviews, analyzes and reports on quality discrepancies related to processes.
Administrator for QMS related business systems such as QMS document control, QMS record controls and QMS learning management. Improves training and auditing along with following up with process owners for lean, focused improvements while leveraging the Plan-Do-Check-Act (PDCA) cycle.
Skills Required / Qualifications
Problems solving methodologies such as 8D (Eight Disciplines) and PDCA (Plan Do Check Act). Knowledge and application of quality concepts such as Lean Manufacturing, 5s, MUDA (Waster Elimination), Six Sigma, ISO 9001, ISO 22301, and ISO 14001 are desired. Certified Quality Engineer (CQE) is a plus.
Education and Training
5 + years of experience and a B.S. in a technical discipline or equivalent working experience in a Quality Management environment is required. Masters Degree in engineering or business administration preferred.
Knowledge of quality related management standards (ISO 9001) and product regulations affecting semiconductor manufacturing related to capital equipment products including the Copy Exactly (CE!) methodology.
Member or knowledge of ASQ.org is desired.
Position Responsibilities and Key Focus Areas
- Manage and improve the maturity of the Quality Management System (QMS) and Corrective Actions process (CAR)
- Prepare, manage, and conduct internal quality systems audits for deficiency identification and correction
- Develop, implement, maintain and improve business unit wide quality assurance systems, including tools, policies, training and processes
- Leads problem solving teams utilizing 8D methodology.
- Manages quality data for accuracy and report generation.