Quality Systems Data Specialist 1 CR

• Education / Educación: 

• University Bachelor’s degree in Business Administration, Engineering or related career.

 

• Specialized Knowledge (Desirable) / Conocimiento especializado (preferible): 

• ISO 13485, 21 CFR 820.

• PLM and Oracle Software.

• Power BI.

• Minitab.

• Any data analysis tool. 

 

• Languages ​​required for the position (Desirable) / Idiomas requeridos para el puesto (preferible): 

• Spanish/English (advanced).

 

• Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido: 

• Microsoft Office

   

• Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:

Support Operational Excellence program and initiatives. 

Provide support to the control of KPIs and other metrics.

Support local and extended CSPOs, VIP projects, improvement initiatives, NPIs, Product transfers, implementation of new technologies. 

Support, as requested by the supervisor, resources administration.

Support and promote the implementation of EHS programs to ensure people safety and environment health.

Promote an environment of integration and engagement among coworkers. 

Make decisions based on a risk thinking, implement tools as PFMEA, Fault Tree Analysis (FTA) and risk evaluation.

Lead CAPA, Internal Audit (IA) investigations and NCE assessments related to Quality Systems.

Ensure investigations and assessments are completed on time.

Create and modify QMS procedures as required. 

Lead and/or support cost saving and continuous improvement projects.

Participate in daily management meetings, support prioritization of daily activities based on business needs.

Coordinate CAPA and Internal and External Audits systems.

Facilitate and review CAPAs, IA and NCEs.

When participating in NCEs, confirm the materials are identified, segregated and quarantined as required

Escalate to the supervisor any non-conformance that may affect product quality or QMS compliance.

Provide guidance to engineers, supervisors, and applicable employees, about CAPA/NCEs/Internal and External Audit requirements and assessments.

Maintain adequate communication channels and close relationships with key partners as Production, Supply Chain, Manufacturing Engineering, Quality, NPI and Corporate Quality Systems, among others.

Perform gap assessments against new versions of the standards and regulations. 

Develop, maintain and optimize data models and dashboards for Quality metrics. 

Ensure data integrity, structure and traceability of Quality Systems information across digital platforms, including data governance and standardization activities. 

Perform data analysis and reporting to identify systemic issues, support decision-making and drive continuous improvement in Quality organization. 

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• Qualifications / Cualificaciones: 

Teamwork

Planning and organization

Focused on goals

Decision making and problem solving

Leadership

Policies and procedures

Written and Oral communication

Customer service skill

Sense of urgency