Quality Systems Specialist 2 CR
Description:
Quality Systems Specialist 2 CR
Alajuela, Costa Rica
+ **Education / Educación:**
University Bachelor’s degree in Business Administration, Engineering or related career.
+ **Experience / Experiencia:**
At least two years in related positions.
+ **Specialized Knowledge (Desirable) / Conocimiento especializado (preferible):**
+ ISO 13485, 21 CFR 820.
+ PLM and Oracle Software.
+ **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.
+ 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 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.
+ Lead, develop and execute cost saving and continuous improvement projects.
+ Participate in internal, external audits as well as inspections from regulatory agencies, in roles that include logistics and leadership.
+ Actively participate in adoption of new or revised regulations/standards, activities include gap assessment, changes implementation and provide guidance to the organization in the development of new activities.
+ Participate in early activities of NPI process, providing guidance on quality systems topics and discussions.
+ Train applicable personnel in regulation and standard requirements and its application to Hologic business.
+ **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