Title:  Quality Engineer

Quality Management System / Responsible Sanitario (Health Officer)

Overall purpose of the role:

• Establish and maintain Quality Management System (QMS) for regulation compliance and facilitate the business of Mindray Mexico
• As the interface with HQ quality center, align the quality management requirement from HQ, communicate and cooperate with different process owners in Mindray Mexico to improve the Quality Management System.

Key Responsibilities :

• Overall responsibility for maintenance of Mindray Mexico’s Quality Management System to assure its continuing compliance, suitability, adequacy and effectiveness.
• Create documents of the QMS, implement them, organize them, store them and improve them, for example, quality manual, quality policy and objectives, organization chart, control of used equipment, equipment calibration, legal file of every product, legal file of every customer, Standard Operation Procedures (SOP), record formats, importation files, validation reports, CAPA system, etc.
• Monitor and assess new quality local regulatory requirements and adjust processes when required. Notify functional management about relevant changes.
• Responsible for internal audit and supplier evaluation and audit when necessary.
• Responsible for external audit (COFEPRIS, customers, etc.) to assure relevant quality license or certificate effective to support product registration or business.
• Responsible for quality related training, including training planning and training organization
• Work with functional department to establish the procedures in accordance with regulations and ensure defined procedures are carried out. Such as:

• Implement and monitor the local labeling activity according to the applicable NOM. 
• Validation of the cold distribution network.
• Providers evaluation and qualification.
• Inspection of facilities and equipment, as long as qualification and validation.
• Handling complaints and product recalls.
• Product destruction control.
• Risk management.
• Personal training.
• Product release.   
• Inform functional management about significant deviations and complaints.
• Deviation Management in conjunction with the different stakeholders as applicable. Local investigations may relate to product damage, artwork and labeling errors, counterfeits, temperature excursions during transport or issues with contract manufacturers or logistics service providers, etc.

• Measuring compliance with specifications, objectives, and evaluation of performance indicators.
• Collect the data and evidence that demonstrate that the QMS was performed, implemented, maintained, and improved.
• Participate in QMS management of other Mindray subsidiaries in Latin America

Technical.

• Bachelor’s degree and appropriate skills in Quality, it is mandatory to have professional license to be the Responsible Sanitario (Health Officer).
• The profession of the Health Officer must comply with the provisions of Article 260 of the General Health Law and NOM-241 (Chemistry, Pharmacist, QFB, QFI, IBM, IBQ, etc.).
• 5 years of experience in quality of medical devices industry.
• Knowledge of cold distribution network for IVD products.
• Intermediate English communication skills, verbal and written.