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 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. (Desirable mastery). 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
130,000 - 140,000 MXN. Plus benefits above the ones given by law.