Quality Sys Spec I

Bio-Rad Laboratories; Tamaulipas; Presencial; MXN 461,000 - 647,000; Jornada completa

Descripción de la vacante

A leading health products company in Mexico is seeking a professional to manage incident and return processes while ensuring compliance with quality management standards. Candidates should have experience in health product companies and knowledge of applicable regulations. Strong analytical skills and familiarity with SAP are essential. This role focuses on maintaining efficient processes and supports audits.

Formación

• Knowledge of regulations applicable to DM IVD.
• Experience with quality processes including product release and incident monitoring.
• Ability to interact across various levels and areas.

Responsabilidades

• Manage incident and return processes, ensuring efficiency.
• Control the QMS documentation system for audits.
• Provide solutions to complex data analysis problems.

Conocimientos

Knowledge of QMS

SAP system management

Attention to detail

Administration and Time Management

Deep analytical aptitude

Descripción del empleo

Snapshot Of Your Day

• Trigger and conclude all activities related to the process of incidents and returns
• Collect information and follow up until the conclusion of the complaints process
• Generate the back labels (legal labels) of the products in a timely manner prior to the conclusion of the period to deplete inventories.
• Execute the planning regarding the generation of evidence for audits
• Keep the bases of the SGC updated
• Ensure that the SGC documents are current
• Carry out the activities as Assistant of the UTV for issuing the five-year report, analysis of trends, implementation and training of the current applicable regulations

How You Will Make An Impact

• Maintain control of the incident and return process that keeps the areas working together continuously and reduces the execution times of actions in the inventory.
• Maintain control of the QMS documentation system in order to respond in a timely manner to planned and unplanned audits (auditing the system documentation)
• Provide solutions to extremely complex problems in which data analysis requires an evaluation of intangible variables.
• Update controls, build and maintain files of documents and correspondence sent and received by the Authority in accordance with the processes agreed at global and local levels.

What You Bring

• KNOWLEDGE
• Knowledge of the regulations applicable to DM IVD - Knowledge of QMS
• Knowledge of the Technovigilance process
• Management of the SAP system SKILLS
• Ease of interacting with different areas at different levels to achieve objectives
• Attention to detail
• Administration and Time Management
• Ease of issuing Quality documentation
• Technological adaptability
• Management of new technologies
• Deep analytical aptitude
• Id discrepancies, patterns and trends to see possible risks - Tolerance to frustration

Work Experience

• Having worked in companies with health products
• Having participated in Audits
• Experience in quality processes including product release and incident monitoring

Legal Entity: (MEX_1103) Bio-Rad, S.A.