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You as Sr Engineer, Quality is responsible for securing the activities of the Baxter Cartago plant related to: Risk Management Framework (when applicable); Complaints System; CAPA procedure (when applicable); Hold system; FCA (Field Corrective Actions); Important metrics connected to the area; Local/regional/corporate forums concerning complaints, risk, and CAPA within the field. Ensuring consistency in compliance with the established requirements (QSR's, Quality Standards, ISO Standards, Baxter Quality Manual, Divisional Specifications, Local Procedures, among others), for such systems.
Job Responsibility:
Ensures that evaluations of complaint samples are accomplished satisfactorily, conducts the manufacturing investigation of the complaint, and establishes effective communication with Product Surveillance to ensure that the complaint system is completed within the defined timeframes
Work as a team with staff from other areas to define the root cause of non-conformities, ensuring that all elements of the CAPA process are clearly detailed (where applicable)
Ensures that the risk system is implemented in the plant and performs analyses that allow the risk to be evaluated, controlled and identified, as well as handling the residual risk (when applicable)
Ensure the Hold and FCA process (when applicable)
Collaborate with the realization of periodic meetings of Quality Data Review and Management Review
Evaluates, develop and improves procedures related to their areas of responsibility
Keeps track of quality indicators and makes action plans for improvement
Hold regular meetings with your staff to maintain adequate communication and information among your team members
Ensures accurate communication with the production areas about the main problems of product complaints
Actively participates in projects to reduce market complaints
Requirements:
English Language Proficiency
Applying tools for problem solving
Management of statistical concepts for data analysis (trend analysis, control charts, Pareto, among others)
Application of tools for data visualization (Excel, Power BI, Minitab, among others)
Learning agility
Motivation and development of others
Very good analytical/statistical problem-solving skills
Data-driven decision-making
Collaboration (partnership and good interpersonal relationships)
Excellent communication, planning, organization and execution skills, as well as prioritization of their activities
The position requires dynamism and initiative to complete the assigned work
Oriented to the fulfillment of objectives and fulfillment of goals
Ability to connect with people to work in a team
Production, Industrial, Chemical, Systems, Electrical, Electronic, Electro-mechanical Engineer or related career
At least 4 years working in production processes at Baxter or a comparable background in the manufacturing industry with Quality Systems