Descripción y detalle de las actividades
responsibilities: - implements policies and procedures to enhance the quality system, advises on methodologies regulating product quality: iso 13485:2016, 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 requisitos
experience 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 13485-2016, fda-qsr’s, eu mdr, health canada, tga, etc.). -application of risk management and iso 14971-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 13485:2016. 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