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Quality System Specialist P1 CR

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Regulatory & Quality Assurance
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Qualifications:

-       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

 

Education:

-       University Bacherlor's degree in Business Administration, Engineering or related career.

 

Experience:

-       Minimum 1 year of experience in positions of a similar nature.

 

Specialized Knowledge:

-       SO 13485, 21 CFR 820.

-       PLM and Oracle Software

-       Advanced English

 

Summary of duties and responsibilities:

-       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.

-       Support budget planning and control of its execution.

-       Create and modify QMS procedures as required.

-       Support cost saving and continuous improvement projects.

-       Participate in daily management meetings, support priorization 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.

 

 

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