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 OneMedical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Paid Parental Leave
Tuition Reimbursement
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.
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.
#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
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice . 137045 By applying, you consent to your information being transmitted by Jobcase to the Employer, as data controller, through the Employers data processor SonicJobs.
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