Supplier Quality Assurance Lead

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

Your role at Baxter

Saving and Sustaining Lives at Baxter begins with the suppliers who make the many raw materials that form our products. As a Supplier Quality Assurance Lead you will have the opportunity in a high visibility role to ensure that Baxter’s suppliers continue to enable our Mission by providing high quality, safe, and effective products. You will work with our Americas Raw Materials suppliers throughout their lifecycle from onboarding, maintenance, to transfer/decommissioning primarily through leading supplier audits and New Product Introduction (NPI) teams.

What you will be doing

• Set Quality system requirements to suppliers, including those for services, indirect quality relevant purchases (non-BOM), and QS requirements for suppliers in global markets.
• Perform Qualification of suppliers to medical device, pharmaceutical, combination devices, and/or biologics standards and oversee their placement on the Approved Supplier List (ASL), including ensuring the creation and maintenance of supporting evidence (Supplier Master File).
• Conduct and oversee supplier audits-qualification and re-qualification, including finding closure; Collect, trend and report supplier quality metrics
• Improve/develop quality systems at selected suppliers for QMS and compliance improvement
• Develop purchasing controls processes, procedures and systems, including those for BOM, non-BOM, services, spare parts and Third Party Finished Goods
• Evaluate and improve the effectiveness of purchasing controls and supplier quality processes and procedures, including Quality Agreements
• Assist in preparing for and defending Purchasing Controls in inspections by external agencies or internal Baxter audits of Purchasing Controls processes; Manage and oversee Purchasing controls CAPA, including root cause identification, and effective and timely closure
• Develop and/or deliver training to internal teams and suppliers.
• Execute SCAR management, effective and timely closure and Review/risk assessment of Supplier Quality Notifications and their escalation to SCARs and NCR where needed
• Accountable for NCR as assigned, conducting NCR timeliness and effectiveness reviews, and trending for corrective/preventive actions,
• Coordinate duties and responsibilities of acquisition or divestiture with the facility, develop/execute/complete associated protocol and ensure that all requirements have been completed and facility is live or divested in the GSQ TrackWise database
• Support Manufacturing, Regulatory, Quality and Purchasing organization for third party suppliers related activities, as applicable.

What do you bring

• Bachelor's degree in life sciences or engineering
• Requires 5+ years of experience in Quality, Manufacturing, Engineering or related field; cross-industry experience a plus (e.g., automotive, aerospace, combination products, pharmaceuticals)
• Manufacturing/Quality experience is preferred in API, excipients and chemicals. Experience with other commodities relevant to medical devices or pharmaceuticals may also be considered.

• Knowledge of pharmaceutical and/or medical device regulations, e.g., ISO 13485, FDA cGMP, MDR, Eudralex, other global or regional equivalent
• Working knowledge of US and International cGMP for API and Excipients
• Experience in Product/process development and/or supplier quality improvement;
• SQA with technical background, a good knowledge of production/quality development and control methods; CtQ definition, DfSS, SPC, APQP, FMEA, Control Plans, etc.
• Auditing skillsets, up to and including certified SQ lead auditor training; Quality Management System auditing, and where possible, special process auditing skills
• Knowledge of Business Acumen; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her industry, business and organization
• Collaboration an