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.
Experiência 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 mínimal guidance from direct supervisor;
Incentivos
- Superiores a LFT
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario**
- Turno Matutino
**Estudios** Carrera con título profesional
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Disponibilidad p. viajar** Si

📌 Supplier Quality Engineer (Mexicali)
🏢 Masimo
📍 Mexicali