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This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
Job Responsibility:
Ensure the establishment, maintenance and improvement of a quality system that aligns with regulatory, normative and corporate requirements
Approve local specifications and procedures as a Quality representative
Represent the Quality function during audits and with regulatory bodies
Implement strategies to identify, assess, and mitigate quality risks in processes, equipment, and materials
Control the accurate administration of the material and human resources required
Provide guide support to internal and external customers to ensure compliance with plant goals and company standards
Promote improvement, simplification, innovation, and initiatives passionate about meeting regulatory requirements
Represent the Director of Quality in their absence and in strategic committees
Build and complete development and training plans for the members working in the Quality sector
Ensure the continuous training and development of the Engineering teams
Promote a culture of quality, safety and continuous improvement at all levels of the organization
Requirements:
Quality, Industrial, Chemical, Biomedical or related Engineering
10+ years in Quality roles, with at least 5 in leadership positions
Validated experience in quality management systems in the medical, biotechnology or pharmaceutical industry
In-depth knowledge of international laws and standards (ISO 13485, FDA, GMP, MDSAP, among others)
Process engineering, validations and quality controls
Risk analysis and problem-solving tools (FMEA, Six Sigma, CAPA)