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:
Responsible for compliance, validation and providing Quality guidance for process/area responsibilities. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices. Leads and conducts root cause investigations for multi-group projects in the development of continuous improvement and corrective / preventative action philosophies and strategies.
Your Team at Baxter:
Within Quality Ops, 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 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 form 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 You’ll Be Doing:
Organize, review, and perform computer system validation or other software validation related evaluations to support the Master Validation Plan. Support the data integrity initiatives to relevant systems, processes, and equipment.
Evaluate all relevant operational data, reports, statistics, and documentation related to manufacturing process and product performance and product quality, to generate proactive and timely actions when needed to address a quality issue or improve a process.
Assure product compliance to specifications through implementation of inspection criteria and procedures in operation’s processes. Drives quality and manufacturing improvements to ensure our processes are in state of control.
Perform root cause investigation analysis and prepare reports, for negative trends of process or product failures or critical characteristics. Document such actions within the quality system as appropriate (NCR/CAPA). Apply standard operating practices and problem-solving methodology.
Assist in complaint/field return investigations related to manufactured product. Lead product complaint trending monthly for responsible areas. Analyze returned components, recommend corrective actions, and follow-up on multi-functional team responses and implementation of corrective actions.
Lead process improvement projects (scrap reduction, defect reduction, etc.) with little or no guidance.
Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation for responsible areas. Provide guidance to other Quality Engineers for their designated areas as required.
Ability to provide requirements for change control based on procedural requirements.
What You’ll Bring:
Minimum of a Bachelors Degree in Engineering with a minimum of 7+ years related experience, or 4+ years related experience with an advanced degree or proven performance and increasing responsibility within Quality roles.
Ability to work optimally with multi-department and multi-site teams
Ability to lead and organize sophisticated technical problems
Good written and oral communication skills, excellent attention to details
Strong team leader with leadership skills and focus on results
Strong scientific analysis and troubleshooting skills
Knowledge of GMP/manufacturing environment and regulatory compliance for the manufacturing of bulk and finished products and current industry standards related to sterilization, cleaning and other validation processes
Must have the ability to manage people, encourage teamwork and drive decisions.
Six Sigma black belt or ASQ CQE certification highly desirable.
Prior experience interacting with the FDA and other regulated industries is a must.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
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 $104,000 - $143,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than 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, commission, and/or long-term incentive. 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.
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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.
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