Job Description

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. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxters 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.

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 liveswhere your purpose accelerates our mission.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

What we offer from Day One

• Medical, Dental and Vision coverage

• 160 hours of Paid Time Off and Paid Holidays

• 401K match

• Paid Parental Leave

• Tuition Reimbursement

What you'll be doing:

• Work on supplier qualification, re-qualification, SCAR (Supplier Corrective Action Request) management, SNC (Supplier Notice of Changes) management, RAM (Risk Assessment and Mitigation) management, accountable for Nonconformance Report (NCR) as assigned for effective and timely closure.

• Prepare the annual supplier re-qualification/audit schedule and perform supplier audits as a qualified lead auditor as per the schedule.

• Complete the purchasing processes in the systems as Supplier Quality Approver including maintenance of relevant procedures and trouble shooting in the systems.

• Prepare for and defend Purchasing/Supplier Controls in inspections by external agencies or internal Baxter audits of Purchasing Controls processes.

• Support Business Units, Manufacturing, Fulfillment, Regulatory, Quality and Purchasing organization for third party suppliers related activities, as applicable.

• 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/implement/complete associated protocol and ensure that all requirements have been completed and facility is live or divested in the SQLM TrackWise database

• Support Manufacturing, Regulatory, Quality and Purchasing organization for third party suppliers related activities, as applicable

• Perform other duties incidental to the above and assigned by supervisor

• Knowledge of pharmaceutical and/or medical device regulations, e.g. ISO 13485, ISO 14971, FDA cGMP, MDD, Eudralex, ICH Q series, other global or regional equivalent are preferred.

• For SQA with technical background, a good knowledge of production/quality development and control methods; CTQ definition, DMAIC, SPC, APQP, FMEA, Control Plans, etc

• Auditing skillsets, up to and including certified Supplier Quality lead auditor training; Quality Management System auditing, and where possible, special process auditing skills.

• Collaboration and Teamwork: Good communications, facilitation, coordination and team skills.

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

• Ability to manage the Quality relationship with assigned key suppliers/stakeholders.

• Experience in Product/process development and/or supplier quality improvement; Good knowledge of production/quality development and control methods in healthcare industry.

• Experience auditing pharmaceutical and/or medical device manufacturing facilities.

• Experience in root cause analysis, corrective and preventive action methods; Expertise/experience in problem solving with quality tools such as 6-sigma / 8-D / CAPA / FMEA / 5WHY etc.

What you'll bring

• Bachelor's degree in a scientific field with 5-7 years of experience required or Master's degree in a scientific field with at least 5 years in relevant discipline.

• Requires 5+ years of experience in Quality, Manufacturing, Engineering or related field; cross-industry experience a plus (e.g., automotive, aerospace, combination products, pharmaceuticals)

• Experience performing laboratory methods.

• Experience auditing Medical device and drug manufacturing facilities.

• Experience in root cause analysis, corrective and preventive action methods; Expertise/experience in problem solving with quality tools such as 6-sigma / 8-D / CAPA / FMEA / 5WHY etc

• Experience with data analysis and reporting using basic Excel toolkit and advanced statistical /process packages such as Minitab or Visio and PowerPoint.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $76,000 - $104,500 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than that of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

#LI-BAXGEN

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.


EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

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.

Recruitment Fraud Notice

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Job Tags

Holiday work, Worldwide,

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