Recibir nuevas ofertas de empleo por email
- ...General Description The ISO Security Specialist is responsible for maintaining the security, integrity, availability, and compliance of the organization's network security environment. This role combines hands-on security operations, governance, compliance, risk...SugeridoPrácticaPatrocinio de visaInicio inmediatoTrabajo híbrido
- ...Buscamos Auditores de Campo altamente motivados para recolectar información periódica de investigación de mercado, en el canal de retail (tiendas de barrio, minimarket, supermercados, farmacias, etc.) a través de un dispositivo electrónico que permite obtener una información...SugeridoLunes a viernes
- ...maintain the Quality Management System (QMS) in compliance with ISO standards, regulatory requirements, and customer specifications.... ...and corrective actions. Supervise, train, and mentor Quality Auditors while promoting quality awareness throughout the organization....SugeridoTemporalTurno de tardeTrabajo por turnos
- ...áreas operacionales limpias, organizadas, seguras y listas para auditorías. ~ Apoyar actividades de control de inventario de laboratorio... ...Requeridas: Lean Manufacturing / Six Sigma ISO 9001 Process troubleshooting Statistical process monitoring...SugeridoPrácticaTiempo completoTurno rotativoTrabajo por turnos
- ...informes de servicio de forma puntual y precisa • Apoyar en auditorías internas y externas relacionadas con los procesos de calibración... ...de Estado de Puerto Rico (valorado) • Conocimiento de la norma ISO/IEC 17025 - un plus, no indispensable • Vehículo propio...SugeridoTiempo completoCon coche propioFin de semana
- ...EMS standards. Coordinate and perform internal audits to ensure compliance with the EMS as a Lead Auditor. Follow up and completion of Corrective Actions associated with ISO in Benchmark. Participate in the External Audit for ISO Certifications and support other Baxter...SugeridoContratistaTemporalTrabajar en la oficinaInicio inmediatoTurno de noche
- ...Devices, Pharmaceutical, or Biotechnology. ~ Knowledge of GMP, ISO 13485, FDA regulations, and quality management systems. ~... ...functional teams and external suppliers. ~ ASQ CQE, CSQP, Lead Auditor, or Six Sigma certification preferred. ~ Proficiency in English...SugeridoTemporalTurno de mañana
- ...procesos relacionados. Elaborar análisis financieros y presentar recomendaciones que apoyen la toma de decisiones. Coordinar auditorías internas y externas, así como el cumplimiento de obligaciones fiscales y regulatorias. Liderar, desarrollar y supervisar al...SugeridoTiempo completo
- ...reportes requeridos para el negocio. # Hacer revisión y entradas de nóminas. # Compilar, analizar y proveer información financiera a auditores en el proceso de auditoria. # Creación de cuentas basadas en los requerimientos del manufacturero y creación de “schedules”. #...SugeridoTiempo completoTrabajar en la oficina
- ...Experience in manufacturing assembly preferred. Comply with established standards, practices, and regulations from Quality (including ISO ****); HSE (including ISO *****); and Human Resources, including the Employee Handbook, Attendance Policy, Code of Conduct, among...SugeridoTemporalLunes a viernes
- ...English/Spanish preferred. Preferred Qualifications Sterile / combination drug-device manufacturing background. Experience with Kneat. ISO 14971 / FMEA experience. Cleanroom / ISO 14644 experience. Validation leadership experience, where applicable....SugeridoContrato
- ...multiple tasks at the same time. Able to work Holidays, extra hours, or any shift when required (e.g. Shutdowns, external audits-FDA, ISO 9002, Corporate-, special projects). Must keep the work area clean and in order conditions. Qualifications: ~ Associate or...SugeridoTemporalTrabajo por turnos
- ...chain activity and accounting systems. Own the process of producing the documentation of controls, tooling, and decisions that our auditors, underwriters, and institutional counterparties expect. What We’re Looking For Mastery of Solidity and the EVM; you can read...SugeridoTiempo completoContratoRemotoHorario flexible
- ...Grade C/D clean-room operations, environmental monitoring, bioburden, contamination control, or cleaning validation. Knowledge of ISO 13485 and ISO 14971. Experience with CAPA, remediation, non-conformance management, regulatory findings, complaints, or field issues...SugeridoContrato
- ...information and interacts with upper management. Comply with the rules, practices and regulations established by Quality, including ISO 9001; HSE, including ISO 14001; and Human Resources, the Employee Manual, the Assistance Policy, the Code of Conduct, among other....SugeridoPrácticaTiempo completoTrabajar en la oficinaLunes a viernes
- ...specifications, and change records. Manufacturing processes, engineering concepts, and problem-solving methodologies. FDA QSR, ISO 13485, ISO 9001, GMP environments, MDR, and CMDR requirements (preferred). Validation activities, laboratory testing, statistical...ContratoTrabajo por turnosFin de semana
- ...within a regulated manufacturing environment is preferred. Working knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, ISO 13485, and Good Documentation Practices is preferred. Familiarity with process validation, equipment qualification, automation,...Tiempo completoContrato
- ...business needs. Experience in: Validation (OQ/PQ/TMV/IPM) Validation lifecycle and documentation Regulated environments (FDA, ISO, GMP) Data analysis tools Document management systems The Personality Part: ~ Our Next Piece is someone who treats...Trabajo por turnos
- ...DOE, PFMEA, risk analysis, SPC, and MSA Root-cause investigation and CAPA Strong working knowledge of 21 CFR Part 820, GMP, and ISO 13485 AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Lead IQ/OQ/PQ and process performance qualification activities;...ContratoTrabajo por turnos
- ...qualification & validation leadership (IQ/OQ/PQ) Risk management tools (FMEA, Fault Tree Analysis) Regulatory knowledge (FDA QSR, ISO *****, GMP) Design for Manufacturability (DFM/DFA) collaboration with R&D Change management & ECO execution Data analytics...PrácticaTemporalTrabajar en la oficinaInicio inmediato
- ...Experience with process failure mode analysis and first-time quality. Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations. Proven experience leading FCA and CAPA processes, ideally within a medical...Trabajo por turnos
- ...Velar por la calidad del servicio brindado por cada departamento bajo su dirección, coordinando iniciativas de evaluación cruzada y auditorías internas. 19. Asegurar una comunicación efectiva en todo momento con los clientes, incluyendo y según sea meritorio, realizar...
- ...Plans, Gap Assessments, Validation Protocols (IQ/OQ/PQ), Technical / investigation reports, SOP, and others. * Knowledge of FDA QSR, ISO *****, ISO ****, or GMP environments preferred. · Exposure to laboratory testing, validation activities, or statistical analysis is...Por horaPrácticaTiempo completoContratoTrabajar en la oficinaTrabajo por turnosFin de semana
- ...Engineering within a regulated manufacturing environment. Strong knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, ISO 13485, and Good Documentation Practices. Experience with manufacturing automation, equipment qualification, tooling, fixtures,...Tiempo completoContrato
- ...Devices Design and development of a packaging system for terminally sterilized medical devices as per requirements established by ISO 11607-1 (Part 1: Requirements for materials, sterile barrier systems and packaging systems) and corresponding packaging ASTM and ISTA...TemporalTurno de tardeTrabajo por turnos
- ...background in field corrective actions, CAPA, or product quality management. Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations. ~ Proven experience leading FCA and CAPA processes, ideally within a...TemporalTrabajar en la oficinaTrabajo por turnos
- ...Identify and mitigate potential risks, issues, and bottlenecks proactively Ensure adherence to FDA 21 CFR Part 11 , GAMP , and ISO 13485 standards Enforce cybersecurity, data integrity, and audit trail requirements Stakeholder Communication Act as the...Trabajar en la oficinaRemotoTrabajo híbrido
- ...and growth. General Purpose of the Position Perform most engagements with minimum supervision. Direct and review the work of Auditors and capable of making decisions on some tax matters. When unusual situations arise, present the pertinent information to the...Tiempo completo
- ...matter expert (SME), ensuring successful system implementation, user readiness, and compliance with industry regulations (e.g., FDA, ISO 13485). The ideal candidate has hands-on SAP implementation experience, strong knowledge of GxP environments, and proven ability...ContratoTrabajo por turnos
- ...Manufacturing processes Root Cause Analysis Process Improvement Project Management fundamentals Regulatory compliance (FDA, ISO 13485) Soft Skills Strong verbal and written communication skills Bilingual (English & Spanish) Excellent analytical and...Temporal