Quality System Specialist

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Join an organization and a team where your work matters. Join us now!

Your role at Baxter

As Quality System Specilist uou will effectively maintain the Supplier Quality System (SQLM-TW), Quality Policies of Supplier Quality in Americas, establish a continuous improvement system through ongoing evaluations of current processes and activities/needs in each Americas locations and give support and perform activities to Supplier Quality Global on subjects related to SQ and Opex (Operational Excellence), such as Metrics and SQLM-TW, that involve Supplier Quality System.

What you'll be doing

• Ensure the implementation and compliance of the Supplier Quality subsystems in accordance with the Global Policies, as well as the compliance with all required deadlines. These include: Supplier Evaluation and Selection, Maintenance of existing suppliers, Supplier Complaints (SCAR), Supplier Audits, Supplier Action and Risk Mitigation Plans (RAM), Supplier Change Notifications, and Supplier Terminations.

• Maintain and manage the NSR (New Supplier Requests) system, as well as their execution for all suppliers in Americas.

• Compliance with and management of Regional and Global Metrics.

• Coordination of training and access to SQLM for all Latin American and Caribbean users. Regional Train of Trainers for the Supplier Quality process.

• Regional SME (Subject Matter Expert) for Global Supplier Quality processes.

• Compliance with applicable BPDs and SOPs.

• Perform SQLM-TW system maintenance activities related to SQ Opex.

What you'll bring

• Biochemical Engineering, QFB, or related fields.

• 5 to 8 years in Quality Systems, preferably in Supplier Quality.

• Knowledge of international standards ISO 9001 / ISO 13485.

• Trend analysis.

• Project management skills managing multiple issues of moderate to high complexity relatively independently with minimal supervision/instructions.

• Experience in a medical device, pharmaceutical, or highly regulated environment is a plus.

• Knowledge and experience of Quality Management Systems, GMPs, regulatory guidelines, and statistics is preferred.

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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