Sr. Supplier Quality Engineer
Tijuana, Baja California
Número de empleados
Sitio Web corporativo
Descripción y detalle de las actividades
Regular Job Duties/Responsibilities: *Plan, coordinate, Schedule, execute supplier audits domestically and internationally as required. *Follow up on supplier audits to demonstrate supplier controls required by FDA CFR 820, ISO 13485 and ISO 9000. *Work with sourcing staff to coordinate supplier audits activities as required. *Develops inspection and test techniques to evaluates supplier materials. *Works with suppliers to find solutions to identified problems. *Create written reports and communicate the results clearly and effectively to the auditee and Hillrom management. *Manage and insure timely implementation of supplier Corrective Action Reports (SCARs). *Provide engineering support for nonconforming material (NMR) and Return Material Authorization (RMA) issues. *Remediate Supplier files to support current and business development activity related to acquisition of new businesses. *Verify supplier files are maintained and documented appropriately. *Provide supplier metrics to management. *. Lead the supplier approval process by assessing manufacturing, Quality Systems capabilities and risks.. *Develop Improvement plans for Critical to quality suppliers. *Manages personnel to maintain and reduce the Incoming Inspection cycle time. *Establishes problem solving strategies and work with Manufacturing and Quality Engineers to reduce MRB inventory. *Perform component characteristic analysis to determine inspection status changes.
Experiencia y requisitos
Minimum Entrance requirements: *Education required:B.S Degree in Engineering required. *Desirable Experience: 5+ year qualifying experience, including previous experience with quality auditing, specifically supplier audits. Excellent documentation, communication and excellent problem-solving skills desirable. Knowledge of FDA CFR 820, ISO 13485 and ISO 9000 requirements, strongly desired ISO 13485 Lead Auditor certification. *Bilingual: Oral and written communications in English and Spanish Required.
Número de vacantes