Manager, Manufacturing Empleos | BorgWarner (El Salto)

Operations Manager

Ubicación

Salario:

No proporcionado

Avanos

Fecha de expiración

Hasta nuevo aviso

Requisitos

Educación: Licenciatura preferentemente en Ingeniería. El titular debe tener habilidades comprobadas de liderazgo, visión e influencia en equipos sobre los que tiene y no tiene autoridad directa.
Experiencia: Mínimo 7 años de experiencia en manufactura y mejora continua a nivel gerencial. De preferencia Six Sigma Green Belt o Black Belt, se requiere experiencia en la construcción de sistemas Lean.
Idiomas: Inglés y español (bilingüe).
Competencias: Pensamiento analítico, trabajo en equipo y sólidas habilidades de liderazgo, comunicación, supervisión y relaciones interpersonales. Capacidad para asegurar el cumplimiento de políticas, reglas y procedimientos organizacionales.
Conocimientos técnicos: Experiencia en metodologías de mejora continua, incluyendo Lean Manufacturing, Six Sigma y herramientas de optimización de procesos.

Responsabilidades

Establecer, mantener y mejorar los procesos de manufactura para impulsar la productividad y eficiencia operativa.
Liderar, desarrollar y dirigir los equipos de producción, asegurando el cumplimiento de los estándares operativos, calidad y objetivos de entrega.
Asegurar el control y análisis de la información operativa mediante registros de producción, reportes y análisis de datos para la toma de decisiones.
Apoyar la introducción de nuevos productos, identificando oportunamente necesidades de equipos, recursos y capacidades.
Supervisar las operaciones en piso, garantizando la ejecución conforme a estándares y proporcionando retroalimentación y acciones correctivas oportunas.
Asegurar la disponibilidad de personal requerido mediante la contratación y asignación oportuna de recursos.
Garantizar la recepción, alineación y ejecución del programa maestro de producción (MPS).
Priorizar los requerimientos operativos (diarios, semanales y mensuales), asegurando el cumplimiento de los objetivos del negocio.
Asegurar el cumplimiento de procedimientos, estándares operativos y requisitos regulatorios aplicables (ISO 13485, FDA, entre otros).
Asegurar la disponibilidad de documentación necesaria para la correcta ejecución de la producción.

Quality IVS Projects Engineer

This role ensures regulatory compliance, supports validations, strengthens techn...

Ubicación

Costa Rica , Cartago

Salario:

No proporcionado

Coloplast

Fecha de expiración

Hasta nuevo aviso

Requisitos

Bachelor’s degree in chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering, or a related field
A minimum of 5 years of experience in medical device manufacturing with strong QA expertise
English proficiency at B2 level or higher
Strong analytical and data interpretation skills
Demonstrated ability to work effectively with cross‑functional and cross‑site teams
Ability to manage multiple priorities in a fast‑paced environment
Availability to travel approximately 20–25 days per year

Responsabilidades

Defines project requirements, coordinates execution, and ensures that all deliverables meet regulatory, quality, and timeline expectations
Ensures full compliance of project activities with global medical device regulations—including MDSAP, MDR, ISO 13485, and FDA requirements—as well as the Coloplast Management System
Supports internal and external audits through expert knowledge and documentation readiness
Oversee the creation, maintenance, and training of quality documentation for IVS projects. Responsibilities include managing DMRs, specifications, test methods, risk assessments, and change control activities in accordance with corporate and local requirements
Provides oversight for validations related to processes, equipment, software, and test methods, ensuring alignment with regulatory and procedural standards. The role approves protocols and reassesses validations as needed due to risk, regulatory, or process changes, and leads investigations to resolve abnormal test results
Owns non-conforming events and CAPAs related to IVS projects
Leads process and product risk management activities by identifying, evaluating, mitigating, and documenting risks. The engineer also supports the definition of specifications for legacy products and communicates risk status and KPIs to key stakeholders
Coordinates sample collection for design verification testing and ensure proper testing execution through Production and the QA Laboratory
The role maintains accurate and compliant quality documentation for IVS projects and supports Quality Management Review (QMR) requirements
The engineer provides backup support to QA team members when necessary and makes quality‑related decisions within the authorized training scope, ensuring continuity of quality operations across the site

Lo que ofrecemos

Medical insurance
asociation
gym
cafeteria subsidy
free transportation

Tiempo completo

Supervisor facilities & maintenance

The Supervisor II, Facilities & Maintenance’s primary responsibility is to maint...

Ubicación

United States , Hayward

Salario:

80000.00 - 110000.00 USD / Año

Baxter

Fecha de expiración

Hasta nuevo aviso

Requisitos

2-year degree or equivalent training/experience required
Minimum 2+ years’ experience in a manufacturing environment
Must have experience leading a team
Be familiar with Lean Manufacturing and Six Sigma concepts
Understand the design, installation and maintenance of mechanical, electrical, and pneumatic equipment that support a complex manufacturing plant
Have a thorough knowledge of manufacturing equipment, using blueprints, equipment manuals, specifications, standard operating procedures
Have working knowledge of hazardous chemicals and their disposal, OSHA, EPA, and FDA requirements
Must have very strong verbal and written communication skills, documentation practices (cGDPs)
Must be able to update procedures and modify processes to simplify their complexity and improve efficiency

Responsabilidades

Maintain, improve and control the safe and efficient function of the plant manufacturing and facilities equipment
Establish and manage preventative maintenance systems, schedules, and documentation
Manage all programs pertaining to the areas of safety, quality, cost, and delivery within the department
Ensure a safe work environment is maintained through adherence to safety guidelines and policies
Supervise and direct maintenance and facilities activities for a two (2) shift production schedule
Develop, implement and manage predictive and preventive maintenance program to meet the requirements of FDA 21 CFR Part 820
Document development work including writing procedures, preventive maintenance work order instruction, reports, and validation protocols
Support the site CAPA/NCR system, by owning or supporting investigations
Responsible for overseeing contract services including cleaning, security, pest control, and outsourced facilities preventative maintenance activities
Organize, review, prioritize, and schedule daily Corrective Maintenance (CM) and Preventative Maintenance (PM) work

Lo que ofrecemos

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Tiempo completo

Quality Process Manager

Quality Process Manager will oversee the activities of quality in the production...

Ubicación

Costa Rica , Cartago

Salario:

No proporcionado

Coloplast

Fecha de expiración

Hasta nuevo aviso

Requisitos

Bachelor's degree in engineering or related field
Minimum 5 years’ experience in Quality Assurance Processes
Minimum 5 years’ experience in medical device industry including device laws & regulations
Minimum 5 years supervisory experience
Solid knowledge and experience working with external quality regulations (ISO, FDA, MDSAP) including hosting external QMS certification audits and Third party audits
Demonstrated and impactful experience with product and process qualification, and validations, process improvement, process control and monitoring (SPC)
Demonstrated experience on nonconformance/non complaint product/ process management
Strong root cause analysis experience, CAPA mentoring and approval, value improvement, risk reduction, and cost containment
Demonstrated organizational influence to include, but not limited to compliance excellence, organizational improvement, product-related risk mitigation, and/or manufacturing cost reduction
Minimum B2+ English

Responsabilidades

Supporting the quality team in production across all value streams, through training, coaching, and guiding lower-level employees to ensure that they comply with the Quality Management System (CAPA, NC, Change Control, Document Control, Audit, production - and quality procedures etc.)
Communicates quality standards and KPI metrics to the team, and other relevant stakeholders
Manage and optimize processes to ensure that the team complies with products specifications for quality
Identify, lead, and implement quality processes, including changes to procedures, while supporting the integrity of the Quality Management System
Identify continuous improvement opportunities including performing complex analysis and present relevant metrics to stakeholders, as well as supporting and guiding the Quality Engineers to do the same
Maintain effective quality metrics and define as well as execute activities to resolve decreases in performance and continuous quality improvement
Participate in creation of the department objectives for the fiscal year. This includes project plans, training, development, and other specific work plans
Be a role model of 6S, Lean and disciplined problem solving throughout the organization
Own and manage relevant portion of the Quality budget to ensure effective resource utilization
Participate in internal and external audits as an active member and support the team in the preparation of activities

Lo que ofrecemos

Medical insurance
asociation
gym
cafeteria subsidy
free transportation

Tiempo completo

Project Manager

Buscamos una persona para el cargo de Project Manager para liderar la planificac...

Ubicación

Spain , Leon

Salario:

No proporcionado

PCI Pharma Services

Fecha de expiración

Hasta nuevo aviso

Requisitos

Titulación universitaria en Ingeniería, Farmacia, Química o similar
Experiencia demostrable en gestión de proyectos, preferiblemente en entorno farmacéutico
Conocimiento de las GMPs y recomendable experiencia en entornos de fabricación aséptica
Manejo avanzado de herramientas ofimáticas y de gestión de proyectos (MS Project, Smartsheet, etc.)
Nivel de inglés alto y fluido, tanto oral como escrito
Capacidad de liderazgo, organización y trabajo transversal con diferentes equipos

Responsabilidades

Definir y concretar los objetivos de cada proyecto
Planificar proyectos en todos sus aspectos: actividades, recursos, plazos y costes
Coordinar y dirigir todos los recursos implicados en el proyecto
Mantener relaciones externas clave: clientes, proveedores, subcontratistas, otras áreas de la compañía
Tomar decisiones informadas para asegurar la evolución del proyecto según los objetivos marcados
Implementar medidas correctoras ante desviaciones y proponer ajustes a los objetivos si fuese necesario
Promover los valores y principios de la compañía en la toma de decisiones
Colaborar en la investigación de accidentes, desviaciones e incidentes tanto en materia de prevención como de calidad
Participar activamente en el control y seguimiento del Sistema de Gestión de Calidad y del Sistema de Gestión de Riesgos Laborales

Lo que ofrecemos

Salario competitivo
Seguro de salud + reembolso de medicamentos
Clases de inglés
Descuentos en diversas actividades
Convenio con gimnasio
Programa de referidos

Tiempo completo

Production Supervisor

The Production Supervisor supports and ensures the success of the manufacturing ...

Ubicación

Costa Rica , Cartago

Salario:

No proporcionado

Coloplast

Fecha de expiración

Hasta nuevo aviso

Requisitos

Bachelor’s degree in industrial engineering (B. A./B.S.) or equivalent
English level B1
Minimum three years related experience and/or related training
or equivalent combination of education and experience
At least one year of supervisory experience
Work experience in Manufacturing Industry, FDA or similar regulated industry
Experience working with inventory management systems
Experience improving manufacturing operations using Lean and Six Sigma techniques
Experience with MES or other systems to track and analyze production operations

Responsabilidades

People management responsibilities for the manufacturing floor
Gather and analyze data and implement improvements to production methods, equipment performance, and quality of product
Utilize Lean principles for making improvements
Work with Value Stream Planner on build plan adherence to ensure customer satisfaction
Work with supply chain, warehouse, and materials on inventory accuracy
Partner with other departments on production requirements for project support
Responsible for PDPs/Reviews for staff
Partner with engineering and Operations Development on trouble shooting equipment/processes issues
Work with finance on identification of adjustments to work order/inventory/improvement opportunities
Assist Leads and direct reports in analyzing and resolving work problems

Lo que ofrecemos

Medical insurance
asociation
gym
cafeteria subsidy
free transportation

Tiempo completo

Process Specialist

The Process Specialist is a key technical contributor within Operations, respons...

Ubicación

Costa Rica , Cartago

Salario:

No proporcionado

Coloplast

Fecha de expiración

Hasta nuevo aviso

Requisitos

Bachelor's degree in material engineering, chemical engineering, or related field
English level B2
Minimum three years related experience and/or related training
or equivalent combination of education and experience
Work experience in FDA or regulated industry
Knowledge in MS Office
Knowledge in ISO 17025, ISO 9001, ISO13485

Responsabilidades

Production plan adherence to ensure internal customer satisfaction
Ensure the execution of scheduled maintenance activities, process perspective approval
Supervision of external maintenance provided by suppliers on assigned machines or equipment
Organization of training for other employees where required. (Chemical/Process/technology related)
Exploring and solving technical problems together with suppliers, technical staff, and operators
Ensure to meet the required levels of Safety, Quality, Output and Cost (DVC/Fixed cost)
Create, update and implement process documentation related to VS production
Cooperate with the calibration/validation team in re-calibrating quality assurance tool used in VS
Participate in monitoring and developing specifications and measurement methods in relation to product quality
Investigate internal customer complaints, develop and introduce preventive and corrective actions

Lo que ofrecemos

Medical insurance
asociation
gym
cafeteria subsidy
free transportation

Tiempo completo

Innovation Project Engineer

The Senior IVS Project Engineer is responsible for ensuring the completion of IV...

Ubicación

Costa Rica , Cartago

Salario:

No proporcionado

Coloplast

Fecha de expiración

Hasta nuevo aviso

Requisitos

University degree in Industrial Engineering, Quality, Production, Supply Chain, or equivalent
Minimum 3 years of experience in medical device manufacturing with a deep knowledge of project management methodologies and standards
Able to work at a high level with minimal supervision
Experience leading multidisciplinary teams
Proven ability to solve problems creatively
Strong familiarity with project management software tools, methodologies, and best practices
Proven ability to successfully complete projects according to defined scope, budget, and schedule
Excellent numerical skills and understanding of data analysis
Minimum English level B2+ in reading, writing, and conversation
Able to travel approximately 20-25 days per year

Responsabilidades

Responsible for analyzing and defining the scope of projects within IVS Project Management, Global Quality
Ensure the successful completion of the project within the scope, schedule, and budget
Establish and maintain project governance, standards, methodologies
Ensure project status and relevant decisions within the project are communicated to all team members and stakeholders
Ensure standardized templates, tools, and systems, that are effective and continuously maintained together with the PM & PMO community in CP
Coordinate and manage local projects
Monitor and manage resources and budgets across portfolio
Responsible for reporting status, KPIs, risks, and issues to the Head of Project Office and the Steering Committee
Provide regular reporting to senior leadership on portfolio performance, risks, and benefits realization
Regular engagement of key stakeholders to align on expectations and needs

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Manager, Manufacturing

Responsabilidades

Requisitos

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