- Verify company's adherence to the established Quality System and GMP/ISO standards.
- Conducting NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process.
- Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements.
- Executing IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, typically with mentorship from higher level engineering.
- Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.)
- Bachelor ́s Degree Engineering.
- 0-3 years of experience.
- Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
- Knowledge of statistical, data analysis.
- Knowledge in process improvement tools such as: Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma or Process Control & Monitoring (SPC), Quality Tools.
- Knowledge with control of nonconforming material, corrective and preventive actions.
- Knowledge of FDA, GMP, and ISO 13485 regulations.
- Intermediate Command of English.
- Shift Admin
- Prior medical device industry experience.
- Previous Quality Engineering experience.
- Experience with SAP ERP System.
- Knowledge on product and process qualification and validation.
- 1 - 2 years experience in Quality or Engineering positions.
-
Quality and Reliability Engineer
hace 2 días
Infotree Global Solutions Heredia, Costa RicaHorario: Administrativo (Lunes a Jueves 7:00am - 5:00pm y Viernes 7:00am - 2:30pm) · - Temporalidad: 03 Meses · - Sede: Heredia, Zona Franca Metropark (100% On-Site) · - Bachillerato universitario deseable (a finalizar), o puede ser negociable por la experiência. · - ISO 13485 de ...
-
Quality Assurance Engineer
hace 17 horas
Infotree Global Solutions San José, Costa RicaEs responsable de probar sistemas y procedimientos para garantizar que se cumplen las normas técnicas. Identificar los problemas técnicos y también de llegar a la causa del problema. Además recomiendan proactivamente soluciones que mejoren la durabilidad y el rendimiento general ...
-
Quality Engineer
hace 1 semana
Philips Alajuela, Costa Rica**Job Title**: Quality Engineer · Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. · But it's not just w ...
-
Quality Engineer
hace 1 semana
Freudenberg Medical srl. Alajuela, Costa RicaWorking at Freudenberg: "We will wow your world" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 51,000 employees a networked and diverse environment where everyone can thrive individually. ...
-
Quality Engineer Ii
hace 1 semana
Abbott Laboratories Alajuela, Costa Rica**About Abbott** · Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. · **Working at Abbott** · At Abbott, you can do work that matters, g ...
-
Quality Engineer Iv
hace 1 semana
Abbott Laboratories Alajuela, Costa Rica**About Abbott** · Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. · **Working at Abbott** · At Abbott, you can do work that matters, g ...
-
Jr. Quality Engineer
hace 1 semana
Cardinal Health Alajuela, Costa Rica**Summary** · Participates in the quality engineering functions related to validation and Supplier Quality related with the project Craft. Works directly with Engineering to assure quality considerations are adequately covered in validations and supplier quality. Position is expe ...
-
Quality Engineer Iii
hace 1 día
Abbott Laboratories Alajuela, Costa Rica**_MAIN PURPOSE OF ROLE_** · An engineering professional who applies scientific knowledge, engineering knowledge, mathematics, and ingenuity to complete assignments related to a specific technical field or discipline. · Provide Quality support to manufacturing, helping to ensure ...
-
Supplier Quality Engineer
hace 2 días
Philips Alajuela, Costa Rica**Job Title**: Supplier Quality Engineer · **Supplier Quality Engineer** · Implement Quality Engineering, Purchasing Controls and Supplier Quality processes related to the development, procurement and continuous improvement of manufacturing materials, components, software, sub-as ...
-
Sr. Quality Engineer
hace 6 días
Abbott Laboratories Alajuela, Costa Rica**About Abbott** · Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. · **Working at Abbott** · At Abbott, you can do work that matters, g ...
-
Quality Engineer I
hace 1 día
Abbott Laboratories Alajuela, Costa RicaMAIN PURPOSE OF ROLE · An engineering professional who applies scientific knowledge, engineering knowledge, mathematics, and ingenuity to complete assignments related to a specific technical field or discipline. · Provide Quality support to manufacturing, helping to ensure delive ...
-
Quality Engineer I
hace 17 horas
Abbott Laboratories Alajuela, Costa RicaMAIN PURPOSE OF ROLE · An engineering professional who applies scientific knowledge, engineering knowledge, mathematics, and ingenuity to complete assignments related to a specific technical field or discipline. · Provide Quality support to manufacturing, helping to ensure delive ...
-
Quality Engineer I
hace 1 semana
Abbott Laboratories Alajuela, Costa Rica**Job Description**: · **_ MAIN PURPOSE OF ROLE_** · An engineering professional who applies scientific knowledge, engineering knowledge, mathematics, and ingenuity to complete assignments related to a specific technical field or discipline. · Provide Quality support to manufactu ...
-
Principal Quality Engineer
hace 3 días
Ecolab Alajuela, Costa RicaMinimum Qualifications: · Bachelor's Degree in Chemistry or Chemical Engineering. · Two to five years of work experience. · Experience Quality Control Supervisor · Management of Chemical Laboratory Equipment. · Quality management systems ISO 9001, HACCP · Intermediate Excel and E ...
-
Medical Quality Engineer
hace 17 horas
Infotree Global Solutions Alajuela, Costa RicaManufacturing Engineering for Transfer support. · - Elaborate validation and transfer strategies in collaboration with MDT counterparts. · - Review and approve TMV/QBE plan and reports. · - Create engineering rationales in collaboration with MDT counterparts. · - Draft, submit an ...
-
Senior Quality Engineer
hace 1 semana
Freudenberg Medical srl. Alajuela, Costa RicaFreudenberg is a global technology group that strengthens its customers and society long-term through forward-looking innovations. Together with our partners, customers and the world of science, we develop leading-edge technologies, and excellent products, solutions and services ...
-
Quality & Reliability Engineer Ii - 03 Months
hace 3 días
Infotree Global Solutions Heredia, Costa Rica**Open Positions**: · 1 · **Comments**: · Skills importantes FAVOR VERIFICAR ESTOS PUNTOS EN EL PHONE SCREENING · - Mínimo 3 años de experiência en Manufactura, Calidad y/o Dispositivos Médicos. · - Experiência previa en industria médica, en sistemas de gestión de calidad. · - Co ...
-
Sr Supply Quality Engineer
hace 3 días
Abbott Laboratories Alajuela, Costa Rica**About Abbott** · Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. · **Working at Abbott** · At Abbott, you can do work that matters, g ...
-
Quality Manufacturing Engineer 2
hace 1 semana
Philips Alajuela, Costa Rica**Job Title**: Quality Manufacturing Engineer 2 · Quality Manufacturing Engineer 2 · **Overview** · Oversees the Quality Assurance in the processes related to the manufacturing of materials, components, sub-assemblies, and completed products and their supply chain, including comp ...
-
Quality Engineer Costa Rica
hace 1 día
Riverpoint Medical Alajuela, Costa RicaRiverpoint Medical is looking to hire a **Quality Engineer **for our new facility in Costa Rica. At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical ...
Quality Engineer I - Alajuela, Costa Rica - Abbott
Descripción
The Opportunity
This position works out of our Costa Rica – Alajuela location in the Electrophysiology Division. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
As the Quality Engineer I, you will be responsible to work closely with Manufacturing and Engineering on sustaining activities to ensure compliance with the quality system requirements and achievement of Key Performance Indicators (i.e. NCMR's, MA's, Yield, Cost Reduction projects, etc.) and owns/lead process/product validation activities. Work closely with Research and Development and Regulatory Affairs personnel (internal or external) to obtained support on sustaining activities and during new product introduction to assure compliance with product and regulatory requirements. Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) and audits (External / Internal)
What You'll Do
Required Qualifications
Preferred Qualifications