Complaints Engineer

Complaints Engineer
Empresa:

Surgical Specialties México, S. De R.L. De C.V.



Puestos Vacantes:
2

Área:

Otros

Complaints Engineer

Detalles de la oferta

•Primary contact for all customer experience reporting and complaint handling activities related to commercial and investigational products. Responsible for independently receiving, documenting, investigation and coordinating responses on product complaints.
•Ensure timely investigation and response to product complaints. Works closely with manufacturing, sales representatives and distributors.
•Participate in investigations and corrective action arising from product complaints.
•Maintain current and complete complaint files.
•Evaluate samples to determine failure root cause.
•Perform collective analyses of product complaints and implement reports for trends and identification of potential corrective or preventive actions.
•Prepare reports to meet international regulations and reporting requirements.
•Ensure applicable domestic and international regulations related to risk management and Medical Device reporting is met.
•Creation of reports for Quality Management.
•Evaluate investigations with engineering department to mitigate failure modes.
•Maintain an effective system of attention, follow-up and action plans for Complaints, FCAs and Product Holds local regulatory requirements, corporate requirements and international standards.
•Capable to understand the processes of the Manufacturing site into the Operational and QMS context.

Experiencia y requisitos:
•Bachelor’s Degree in Engineering. Desirable; Bioengineer, Chemical engineer, Mechanical, Mechatronic engineer)
•Minimum of 4 years experience in Medical Device Manufacturing industry
•Proven ability to work effectively in a team environment through conflict resolution
•Strong interpersonal, organizational, and verbal and written communication skills and the ability to work effectively as a team member
•Intermediate/Advance level in MS Office systems such as; Excel, Word, Outlook.
•Demonstrated working knowledge of ISO 13485 and other medical device related standards.
•Bilingual


Horario: 7:00 a 17:00 hrs.


Fuente: EmpleoNuevo


Área:

  • Otros / Otros

Requisitos

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