Quality System Engineer
hace 2 semanas
Descripción y detalle de las actividades**RESPONSABILITIES**- Expertise regarding current regulatory requirements and international standards.- Performs regulatory and system internal audits to ensure systems are documented, procedures are followed and are adequate according to ISO9001:2015, ISO13485:2016 and 21 CFR Part 820.- Ensure that all the Quality System Procedures are in compliance with the international standards and regulatory requirements.- Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects.- Prepares internal audit plans and identifies the roles and responsibilities of audit team members.- Ensure that internal audit plan is followed and completed according to the approved annual audit plan.- Participate as Internal auditor leader to develop the rest of the internal auditor’s team- Follow up corrective / preventive actions generated by internal and external audits to ensure that are documented and completed properly.- Prepares audit reports by collecting, analyzing, and summarizing operating information and trends and report audit results.- Responsible for the CAPA system, ensuring that all the corrective / preventive actions are documented and closed according to the implemented procedures.- Responsible to complete the effectiveness verification for all the CAPAs generated- Perform and/or lead failure investigations for CAPA and/or audit findings investigations.- Support during internal and external auditsExperiência y requisitos**JOB REQUIREMENTS**- Bachelor’s Degree in Industrial, Electrical, Systems or Mechanical Engineering.- 5+ years of experience in manufacturing environments- Experience participating in Quality Audits- Knowledge of statistical techniques, acceptance sampling, and SPC.**QUALIFICATIONS AND SKILLS**- Knowledge of Quality Systems, ISO13485:2016 Standard- FDA RegulationsBeneficios- Beneficios de acuerdo a la LFT- Aguinaldo superior a Ley- Dias por enfermedad- Seguro de Gastos Medicos Mayores- Dias de descanso superior a Ley**Número de vacantes** 1**Área** Calidad**Contrato** Permanente**Modalidad** Presencial**Turno** Diurno**Jornada** Tiempo Completo**Horario**- Tiempo completo- Turno Matutino- Tuno de 10 horas- Lunes a viernes**Estudios** Carrera con título profesional**Inglés**Hablado: Avanzado, Escrito: Avanzado**Disponibilidad p. viajar** No
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Quality System Engineer
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Quality System Engineer
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Tijuana, México Sctek Manufacturing A tiempo completoWe are looking for a Quality System Engineer who will take the lead in implementing and maintaining Quality Management (QMS) and Environmental, Health & Safety (EHS) systems across our factory operations.This role offers a chance to work in a dynamic international environment, collaborating closely with cross-functional teams in Asia and the Americas....
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Quality System Engineer
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Tijuana, México Sctek Manufacturing A tiempo completoWe are looking for a Quality System Engineer who will take the lead in implementing and maintaining Quality Management (QMS) and Environmental, Health & Safety (EHS) systems across our factory operations. This role offers a chance to work in a dynamic international environment, collaborating closely with cross-functional teams in Asia and the Americas....
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