Quality Systems Specialist 2 CR

• 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: 

Internet, 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