Descripción y detalle de las actividades
•Appraise supplier credentials, agreements and survey responses
• Route new supplier requests for approvals
• Work with suppliers to communicate requirements and establish process controls in alignment with Engineering, Manufacturing, Quality and Business Objectives
• Perform reviews with suppliers to determine manufacturability of components
• Participate in the development of quality requirements for purchased component/assemblies
• Review and develop risk mitigation controls for supplied parts
• Assist suppliers with investigation and process improvement initiatives
• Perform supplier audits (quality system, process and product audits)
• Create supplier performance metrics and report on performance to suppliers and management.
• Ensure alignment of supplier quality metrics with business objectives
• Disposition nonconforming materials and initiate follow up activities to ensure proper corrective action and preclude recurrence of rejections.
• Work with various engineering disciplines to resolve customer return issues related to supplier quality.
• Work with incoming inspection to ensure proper part surveillance.
• Review and approve first articles on custom fabricated components.
Experiencia y requisitos
• Minimum of three years’ experience in quality engineering and/or supplier management, preferably in the medical device industry (note: Supplier management experience in a highly controlled or regulated industry may be considered);
• Knowledge of manufacturing processes, procedures and production equipment;
• Auditing experience and training (ASQ-Certified Quality Auditor and or Lead Auditor Training for ISO 13485
• Familiarity with Quality Standards (ISO 13485, ISO 9001, FDA QSR, etc.)
• Demonstrated knowledge and experience with risk analysis, statistics and quality tools;
• Background with cables, circuit boards, circuit board assemblies and/or molding processes are a plus;
• Ability to travel (domestic & international) up to 25% of the time;
• Strong problem solving ability;
• Strong Analytical Skills;
• Strong Communication skills;
• Excellent Documentation skills;
• Project Management;
• Flexibility and adaptability;
• Ability to work with minimal guidance from direct supervisor;
Beneficios
Supplier Quality Engineer • Mexicali, Baja California
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