• Job Description

  Req#: JR - 110136

  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
  
  Join us as we revolutionize the treatment landscape and help improve patient lives worldwide.

  Baxter plans to spin off our ~$5B Kidney Care segment into an independent, publicly traded company. The new standalone entity will leverage our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. With its own investment priorities and enhanced management focus, the company will be better positioned to pursue growth opportunities and invest in innovation. We will build on our leadership in the kidney care space, fueled by our steadfast focus on innovation, our passion for patients and their families and our expertise in operational excellence.

  This is where you can make an impact.

  This Product Surveillance Associate II is a critical customer facing role in ensuring compliance and timely processing of Complaints, Medical Device Reporting and Customer Letters. This position serves as subject matter expert for PostMarket complaint handling processes.

  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 you'll be doing

  • Writing and submitting MDR submissions in a timely manner.
  • Determination and final decision making for reportability assessment.
  • Responsible for responses to the US customers, including due diligence contacts and letters with investigation results.
  • Triage incoming complaints from internal or external customers to determine next steps in the process based on level of risk.
  • Provides oversight for all assigned complaints and related activities per defined procedures.
  • Timely and accurate processing of high risk and serious injury/death complaints.
  • Collect necessary complaint information per requirements.
  • Determine reportability of device complaints and submit associated Medical Device Reports per regulations. Answer any subsequent questions received in collaboration with key partners (i.e., Regulatory Affairs, Corporate Product Surveillance, Manufacturing).
  • Liaise with Pharmacovigilance on combination drug/device adverse events.
  • Evaluate complaint for need to investigate and coordinate sample retrieval.
  • Liaise with Corporate Product Surveillance function(s), global manufacturing facilities, and 3rd party vendors to investigate complaints.
  • Participate in defining investigation plan, including defining members of Investigation team and their roles and responsibilities, provides follow-up communication (written or verbal) of Investigation results with internal and external customers, as applicable.
  • Timely closure of complaints, as per procedure.
  • Manage workflow; Identify and raise issues.
  • Participate in continuous improvement activities and projects. May lead projects as assigned by management.
    

  What you'll bring

  • Bachelor’s degree (life sciences preferred).
  • 2+ years relevant work experience in cGMP related industry or in a clinical setting.
  • Excellent interpersonal and written/verbal communication skills.
  • Strong analytical and problem-solving skills.
  • Thorough knowledge of applicable procedures, specifications, regulations and standards.
  • Knowledge of the FDA Quality System and Regulatory Reporting regulations (e.g., 21 CFR 803, 806, 820, 211, etc.)

  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 $72,000- $99,000 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. 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-BB1

  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.

• About the company

  Baxter International Inc. is an American multinational health care company with headquarters in Deerfield, Illinois.

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