• Perform various types of audits (quality system, process and product audits)
• Perform reviews with suppliers to determine manufacturability of components.
• Create supplier performance metrics and report on performance to suppliers and management.
• Work as liaison between suppliers and Masimo to ensure highest level of product quality and supplier performance.
• 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 issues related to supplier quality.
• Work with incoming inspection to ensure proper part surveillance.
• Ensure alignment of supplier quality metrics with business objectives.
• Three to five years of experience in supplier management, preferably in the medical device industry (note: Supplier management experience in a highly controlled or regulated industry may be considered);
• Auditing experience and training (Certified Quality Auditor and or Lead Auditor Training for ISO Preferably).
• Familiarity with Quality Standards (ISO 13485, ISO 9001, FDA QSR, etc.)
• Ability to travel (domestic & international) up to 20% of the time;
• Strong problem solving ability;
• Strong Analytical Skills;
• Strong Communication skills in English and Spanish.
• Excellent Documentation skills;
• Project Management;
• Flexibility and adaptability;
• Ability to work with minimal guidance from direct supervisor;
|Área||Control de Calidad|
|Horario||8:00 a.m a 5:30 p.m.|