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As a Supplier Quality Senior Engineer, the role involves developing, planning, and coordinating improvements. These improvements relate to supervising and assuring supplier quality within the organization. This role ensures that external suppliers align with Baxter’s quality system requirements, applicable regulatory standards, and internal procedures. You will lead initiatives to evaluate, monitor, and improve supplier performance, guaranteeing product quality, continuity of supply, and risk mitigation throughout the supply chain. The role requires partnership across multiple departments including Procurement, Operations, Engineering, Regulatory Affairs, and Manufacturing to ensure supplier-related risks are identified, assessed, and controlled in an accurate manner. You will also support investigations addressing nonconformities from suppliers, market complaints, and manufacturing issues connected to supplier performance. The position requires active participation in continuous improvement projects and supervision of personnel engaged in quality assurance related to suppliers.
Job Responsibility:
Lead, review, approve, and supervise the execution of Change Control activities concerning vendors, including evaluation of vendor change notifications
Develop, review, and improve procedures related to the management of supplier quality, including supplier qualification, supplier monitoring, and supplier requalification processes
Plan, coordinate, and participate in supplier audits (onsite or remote), including follow‑up of audit findings and verification of efficiency
Lead Supplier Corrective and Preventive Actions (SCARs), ensuring timely resolution and balanced root cause analysis
Monitor, analyze, and trend supplier performance metrics (quality, delivery, cost, and compliance)
Actively support investigations of non‑conforming material, deviations, manufacturing exceptions, and market complaints with a supplier component
Collaborate with teams from multiple functions in: New supplier qualification
Technology transfer projects
New product introductions
Validation and periodic review activities involving suppliers
Supervise the participation of direct reports or assigned personnel in supplier‑related projects and maintain alignment with training requirements
Ensure supplier-related activities align with regulatory requirements (FDA, ISO, etc.) and Baxter Quality System expectations
Guarantee alignment with Environmental, Health, and Occupational Safety standards applicable to supplier quality activities
Requirements:
Bachelor’s degree or equivalent experience in Materials, Industrial, Chemical, Production, Systems, Electrical, Electronic, Electromechanical Engineering, or a related field
Sophisticated English proficiency (written and verbal)
Minimum 5 years of validated experience in Quality Systems within regulated industries, preferably medical devices or pharmaceuticals
Strong experience in Supplier Quality Management and external supplier oversight
Validated knowledge of: Regulatory standards (ISO 13485, FDA QSR, GMP)
Quality tools (risk management, problem source investigation, CAPA)
Knowledge and experience in Project Management
Leadership skills with the ability to work multi-functionally and balance priorities successfully