Quality Senior Engineer

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