TIEMPO COMPLETO | COSTA RICA
Main Responsibilities
· Manage and oversee the work of assigned team within own function (e.g.,
Quality Compliance) and indirectly manage cross functional or matrix teams
(e.g., SV Documentation) as appropriate. Develop a robust talent development
plan in alignment with functional growth strategies of the department.
· Identify, and lead the implementation of business process improvement
solutions
for Quality Systems as well as for Documentation and PCS processes
and
systems, including developing changes to procedures, to improve operation,
efficiencies, and user experience, while supporting the integrity of the
business
process. Local process owner
for quality system processes and for documentation
and PCS processes and/or
systems.
· Provide with his/her teams first-level support to users of Quality,
Documentation
and PCS Systems, e.g., CAPA, NCR, Change, Training, Maintenance,
with
respect to system usage and process requirements.
· Recommend changes to documentation associated with Quality,
Documentation and
PCS Systems, as well as assessing effectiveness and approving
recommendations of
others
· Lead projects from inception through completion, including developing
and/or
scheduling key milestones, securing and allocating resources, and
representing
quality management on cross-functional teams
· Determine new training and training program improvement needs, including
development of training programs and training materials on quality and/or
compliance topics including Quality Systems (for the latter in collaboration
with
corporate system/process owner), and delivers training
· With his/her team collect and generate metrics, and draw inferences for
improvement opportunities and needs
· Responsible for overall compliance; provide feedback and advice to
process
owners regarding processes to ensure compliance in the site
· Oversee regulatory inspection and external audits and ensure timely
responses are provided during the audit/inspection .
Knowledge and Experience:
· Bachelor’s Degree in science or engineering and 10 years of working
experience
in related field.
· At least 3 years in managerial leadership position
· Previous experience in the medical device or pharmaceutical industry in
quality management or related function in an international environment,
required.
· Proven expertise in MS Office Suite and experience with IT systems that
support
quality processes (e.g., CAPA, Documentation & Change System)
· Excellent understanding of medical devices regulations (e.g., FDA (21
CFR Part 820)
and ISO13485, ISO14971, and MDD)
· Advanced English (85%-90%)
Talent Advisors tiene como misión garantizar que no se limite ni de forma directa ni indirecta las posibilidades de una mujer o de un hombre de acceder a determinado tipo de empleo por su sexo, siempre que cuente con la formación y las habilidades requeridas para el puesto. En Talent Advisors tenemos procesos de reclutamiento donde tratamos igual a quienes están en las mismas condiciones. Tenemos procesos para evitar y erradicar cualquier práctica discriminatoria; promovemos la igualdad y el aprovechamiento de la diversidad de talentos para el trabajo.
Talent Advisors advierte que los requisitos incluidos en este anuncio, serán valorados en el proceso de reclutamiento junto con otras competencias y cualidades adicionales del candidato.
