Descripción y detalle de las actividadesResponsibilities: - 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 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 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
