Quality Control and Testing P06

ob Description
Ensure that our product is functional and safe for the end customer by understanding, developing and
applying quality control systems, as well as analyzing, proposing and implementing improvement of
quality and manufacturing processes, thinking about improving defects in a timely and efficient manner
Evaluate, propose and implement high complexity improvements in processes in the process
quality area, seeking to strengthen processes while improving their efficiency, guided and advised
by the area manager .
Search for solutions to problems identified in the areas of manufacturing and process quality
through the application of Lean tools.
Support assigned root cause investigations (NCRs), as well as the development of action plans and
the implementation of corresponding actions, during the established period of time. Review and
Approve documents for High Impact NCR.
Develop and establish new processes and procedures from a quality perspective based on the Risk system evaluation, be part of the process and product transfer projects from the planning stage to its operationalization with high understanding of the ISO standard and other regulations.
Coach and train colleagues to achieve a high performance team following the department's
purpose, as well as make high-impact decisions evaluating the risk in the absence of the manager
Review and approve quality plans and First Article Plans related to the production process with low to high complexity, as well as propose changes to PFMEAs, this for those projects where you are assigned as a Quality representative.
Perform reviews to OT Core System documents as well as validation/qualification protocols (IQ,
PPQ, IOQ, IO, PR, etc.) where assigned as a quality representative complex and advance system.
Provide support to key company projects, including definition and implementation of controls
aimed at ensuring product quality.
Ensure the order and cleanliness of the areas under your responsibility. (5's) and comply with
quality GO's in the corresponding period.
Do the other functions inherent to the position and those assigned by your immediate manager.
Meet compliance with corporate and legal EHS requirements, by complying with internal policy and procedures. In addition, ensure compliance through the adoption of necessary strategies, internal controls, communication and training.
Continuously maintain EHS results through leadership, commitment and participation in all EHS-related initiatives.
Education:
Bachelors degree in Industrial Engineering Bussiness Administrator or related career.
Desirable CQE (CERTIFIED QUALITY ENGINEER certification) given by ASQ.
Intermediate/advanced English proficiency.
Experience:
Experience of at least 3-5 years as a quality
supervisor/quality engineer in the medical
industry.
Plus: Experience in product transfer, quality
system, validations and manufacturing, new
procedure definition, risk assessment
documentation development.
Skills:
Critical thinking
Focus on excellence
Open and authentic
Project management
Communication
Decision based on data analysis and Risk
approach
Advance Statistical Knowledge

Skills
Quality Control, Data Analysis, Project Management, Documentation

Employment type
Full-time

Work arrangement
No