Descripción y detalle de las actividadesresponsibilities: - implements policies and procedures to enhance the quality system, advises on methodologies regulating product quality: iso *:*, mdd and cmdcas, mdsap, cfr21 parts 820 and 11.- coordinates and manages activities related to corrective and preventive actions, internal audits.- plans, organizes, implements, and controls the internal audit program.- prepares the site for receipt of external audits/inspections.- audits the implementation and effectiveness of the corrective actions system.- maintains and monitors the continuous process verification (cpv) process, working directly with quality engineering and process engineering areas.- prepares monthly reports as required for management and corporate meetings.- coordinates information for monthly quality meetings.- organizes annual good practices training.- maintains constant communication with corporate quality systems personnel to follow up on issues involving both sites, such as standards updates and impact assessments.- coordinates, assigns, and controls activities of the calibration laboratory.supports required quality activities to ensure the quality system remains active and updated.experiência y requisitosexperience and requirements: education: bachelor's degree in industrial engineering, q.f.b., q.b.p, i.f. or related field.specialization in quality systems desirable.experience: 5 years or more in roles related to quality systems in medical device or pharmaceutical companies.advanced english proficiency.competencies: - knowledge of medical industry regulations and standards covered under mdsap (iso *, fda-qsr's, eu mdr, health canada, tga, etc.).-application of risk management and iso *-based strategies.cost reduction.-development and implementation of controls and procedures for good documentation practices in regulated industries.- mastery of administration tools and quality systems.ability to develop, implement, and maintain corrective actions (capa) system in a regulated industry.- standards and equipment calibration processes (iso/iec guide 98).development and implementation of an internal audit program under iso *:*.human competencies: problem-solving skills.quality decision-making.prioritization skills.*número de vacantes* 1*área* calidad*contrato* permanente*modalidad* presencial*turno* diurno*jornada* tiempo completo*estudios* titulo profesional*sexo* indistinto*disponibilidad p.viajar* no