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 *****- Familiarity with Quality Standards (ISO *****, ISO ****, 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 competente**Inglés**Hablado: Avanzado, Escrito: Avanzado**Disponibilidad p.viajar** Si