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Product Surveillance Quality Associate

Req #: JR - 057404 Location Round Lake, Illinois, United States Job Category: Quality Control Date Posted: 01/14/2022

Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

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  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

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Product Surveillance Quality Associate

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. 

The Product Surveillance Quality Associate is responsible for providing oversight for the global complaint handling process and regulatory reporting, as well as identifying, assessing, and working to correct regulatory and quality risks. This position serves as subject matter expert for PostMarket surveillance processes such as complaint handling or Regulatory Reporting.

Essential Duties and Responsibilities

  • Serves as a Subject Matter Expert for PostMarket surveillance processes such as complaint handling or Regulatory Reporting
  • Providing complaint processing timeliness oversight and governance
  • Driving global implementation of the PostMarket Surveillance Processes (complaint handling and regulatory reporting) and system
  • Representing PostMarket Surveillance Processes (complaint handling and regulatory reporting) in new product launches, Quality Agreements, and integrations of acquisitions, including leading assigned activities
  • Leading and/or participating in implementation of new Standards and Regulations
  • Providing oversight and governance (weekly and daily) to the Regulatory Reporting (MDRs, FARs, BPDRs) process to ensure on time submissions. Driving resolution of escalated issues and risks
  • Creating and/or analyzing operations metrics (complaint handling process and regulatory reporting) to identify improvement opportunities
  • Writing, reviewing, analyzing, and revising local and global procedures, including facilitation of PS Change Review Board and TCU document management as needed
  • Partnering with clinicians or with product owners to understand input needed for reportability determination
  • Leading and/or participating in cross functional continuous improvement activities and projects, including NCRs/CAPAs
  • Leading mentoring and training of the PostMarket Surveillance team
  • May interface with regulatory agents or internal auditors and/or lead audit readiness activities
  • May perform other Postmarket activities as assigned

Qualifications

  • Ability to perform all duties required of previous levels
  • Strong knowledge of the FDA Quality System and Regulatory Reporting regulations (e.g. 21 CFR 803, 806, 820, 211, etc.)
  • Strong interpersonal skills
  • Ability to prioritize multiple tasks
  • Ability to lead people and encourage teamwork
  • Customer focus
  • Ability to drive decisions quickly and effectively
  • Proficient with computers
  • Excellent written/verbal communication and organizational skills
  • Ability to make independent decisions with minimum oversight and ability to work independently
  • Strong problem solving, critical thinking and analytical skills
  • Detail oriented
  • Ability to effectively communicate across multiple levels within the organization

Education and Experience

  • Bachelor’s degree (life sciences preferred)
  • 2 or more years of relevant work experience in cGMP related industry or in a clinical setting.
  • Experience with driving process improvement initiatives and projects preferred Application of lean principles preferred

#LI-BAXGEN

#IND-USOPS

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.

057404

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Christelle

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Lorena

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

Gary

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Christelle

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Lorena

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Gary

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

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