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;
beneficios
- 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