Spec, Quality Supplier

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.

Your role at Baxter:

This position participates in supplier quality related to monitoring and improvement of supplier performance. Coordinates problem solving from parts supplied.

#thisiswhere your creativity addresses challenges!

Your team:

Our team is reliable, collaborative, and innovative, we are consistently delivers high-quality products on time. We have a deep understanding of their products and the industry, are open to new ideas, and are quick to respond to inquiries. We operate with honesty and transparency, are committed to continuous improvement, and share Baxter's values and commitment to patient care. We are flexible and adaptable, able to adjust to changing circumstances as needed, and are aligned with Baxter Healthcare's mission and vision.

What you'll be doing

Plan, coordinate, Schedule, execute supplier audits domestically and internationally as required.

Follow up on supplier audits to demonstrate supplier controls required by FDA CFR 820, ISO 13485 and ISO 9000.

Work with sourcing staff to coordinate supplier audits activities as required.

Develops inspection and test techniques to evaluates supplier materials.

Works with suppliers to find solutions to identified problems.

Build written reports and communicate the results clearly and effectively to the auditee and Hillrom management.

Manage and insure timely implementation of supplier Corrective Action Reports (SCARs).

Provide engineering support for nonconforming material (NMR) and Return Material Authorization (RMA) issues.

Remediate Supplier files to support current and business development activity related to acquisition of new businesses.

Verify supplier files are maintained and documented appropriately.

Provide supplier metrics to management.

Own the supplier approval process by assessing manufacturing, Quality Systems capabilities and risks.

Develop Improvement plans for Critical to quality suppliers.

Manages personnel to maintain and reduce the Incoming Inspection cycle time.

Establishes problem solving strategies and work with Manufacturing and Quality Engineers to reduce MRB inventory.

Perform component characteristic analysis to determine inspection status changes.

What you'll bring

• B.S Degree in Engineering required.
• Extensive Knowledge of metals
• 5+ year qualifying experience, including previous experience with quality auditing, specifically supplier audits. Excellent documentation, communication and excellent problem-solving, teaming and communication/interpersonal skills.
• Bilingual: Oral and written communications in English and Spanish Required.
• Knowledge of FDA CFR 820, ISO 13485 and ISO 9000 requirements, strongly desired ISO 13485 Lead Auditor certification.
• Computer competency in Word, Excel, Power Point and databases.
• Practical experience in metrology, test, inspection and analysis techniques.
• Experience in the medical device industry or automotive industry in development and deployment on Quality System and process controls and continuous improvement methods (QSR’s, ISO9000/QS9000, ISO13485).
• Primary/Secondary party compliance auditing experience.
• Ability to work independently.
• Ability to methodically manage projects.

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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