Quality manager

Descripción general

Purpose Statement
The Quality Manager is responsible for designing, planning, coordinating and executing projects oriented towards quality improvement in the site. Establishes and maintains Quality Management systems that meet regulatory requirements, corporate policies, internal policies and business needs. Additionally, he/she is responsible for planning and supervising Quality Engineering functions and activities.

Key Responsibilities
Plan, coordinate and execute projects oriented towards process defects prevention and overall quality improvement.
Review and/or approval of documents, investigations, extensions or another regulatory figure within the company´s quality system, as an alternate representative of Quality Management.
Provide technical support to the Quality area and to other departments.
Coordinate Quality Engineering functions and activities.
Deliver training related to quality technologies.
Coordinate with Corporation the implementation of projects related to the Quality dpt.
Create new procedures and/or improve the existing in order to facilitate and assure regulatory compliance.
Responsible for acting as Subject Expert Matter (SME) of the following chapters of the company´s quality system: 803.5 Individual Adverse Event reports, 820.70 Production and Process Controls, 820.75 Process Validation, 820.60 Identification, 820.65 Traceability, 820.72 Inspection, measuring and test equipment, 820.90 Non-conforming product, 820.80 Receiving, in-process and finished device acceptance, 820.100 CAPA, 820.198 Complaint Files.
Provide support to new products/process transfer projects
May design and implement process control strategies.
May facilitate and support the Quality Control supervision function through Quality Engineers and Quality Supervisors.
May participate as a core team member in the new products transfer process, representing Quality Assurance areas.
May act as NCEP System administrator for the area

Requisitos para aplicar

? Engineering degree in a relevant discipline, Licenciature required.
? More than 7 years of experience in similar positions
? English level required C1: 90-94%