Regional Quality Manager
Responsible for developing quality procedures, tools and methodologies.
Responsible of keeping up to date the ISO 13485 requirements.
Detalles de la empresa
International Medical Devices Manufacturer is looking for a Regional Quality Manager.
Descripción de la vacante
The main responsibilities are:
- Creation and maintenance of the quality master plan (MQP)
- Attend product failures and defects due to supplier quality, monitors the availability of discrepancies validating the implementation of corrective action implementation (CAPA)
- Evaluate NCMR´s metrics to define actions necessary for improvement
- Carry out validations of the CFR agreement part 820. Validation protocols, IQ, OQ, PQ, and maintains the requirements of ISO 13485
- Create, maintain and control the traceability of products (DHR´s)
- Review and approve process risk analysis (PFMEA)
- Responsible for measurements studies, first articles (FAI´s) Gage R&R, SPC´s tools
- Responsible for the selection, training and development of Quality Control personnel
Perfil del candidato
Bachelor's Degree in industrial, electronic, mechanical or similar engineering. 3+ years of experience as Quality Manager in Medical industry and expertise in handling clean rooms. Advanced English is a must. Microsoft Office and Minitab are needed, Oracle and Agile is a plus.
Oferta de empleo
Attractive compensation package plus benefits above the ones given by law.