Quality Associate

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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.

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

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

Quality Associate

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This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

This is where your work makes a difference.

Here, you will find more than just a job—you will find purpose and pride.

Your Role at Baxter

The Compliance Quality Associate is responsible for identifying, assessing, and driving actions to correct regulatory and quality risks within complaint records, to ensure compliance and congruency of complaint records across Regions and Segments. This position serves as a Subject Matter Expert for Postmarket surveillance processes such as complaint handling and Regulatory Reporting. This role is also responsible for process and tools needed to ensure compliance and for driving actions/corrections to the complaint records.

Ability to handle multiple projects and demonstrate effectiveness in task completion, decision-making, empowerment of others, problem solving and leadership. A strong understanding of the complaint management system, procedures, FDA, ISO and Baxter Quality systems is also required.

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

Serves as a Subject Matter Expert for complaint handling and Regulatory Reporting
Establishing and maintaining processes and automation tools to ensure compliance and congruence of complaint records
Monitoring output of the automated tools and proactively identifying potential congruency or accuracy issues within complaint records
Ensuring corrections are made in a timely manner and monitoring results of the corrections and actions
Effectively identifying improvements and leading continuous improvement efforts and projects, including NCRs/CAPAs
Leading audit readiness activities and efforts for Postmarket Surveillance function, including potential risk identification, mitigations, and improvements
Participating in external and internal Audits as a complaint process Subject Matter Expert, including direct interactions with the Auditor(s), providing support to Audit requests, providing support to responses, and driving completion of Audit commitments
Maintaining a high level of expertise in current regulatory requirements
Writing, reviewing, and revising written Procedures and submitting procedural changes as needed
Creating operations metrics/KPI performance data and leading complaint timeliness governance as assigned
Coaching complaint handling team on complaint file documentation, congruency and accuracy
Providing training of the Product Surveillance team.
May perform other Postmarket activities as assigned

What you'll bring

Bachelor’s degree in Science or Engineering required
2-5 years relevant work experience in cGMP related industry
Experience with driving process improvement initiatives and projects preferred
Ability to effectively communicate (verbal and written) across different functions and across multiple levels within the organization
Strong understanding of complaint process and regulatory reporting regulations applicable to Baxter products (medical devices, pharmaceuticals, etc.)
Strong critical thinking and problem solving skills
Ability to work independently and to prioritize effectively
Ability to drive decisions and actions quickly and effectively
Ability to make independent decisions
Understanding of scientific strategies and ability to invent new methods or new avenues of analyzing large data
Good project management skills
Collaboration and Teamwork
Detail Oriented
Strong technical writing skills

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.

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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Address

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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.”

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.”

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.”

Join Our Talent Community

We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.

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Quality Associate

Overview

Success Profile

Quality Associate

This is where your work makes a difference.

Your Team at Baxter

What you'll be doing

What you'll bring

Address

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Hear from Our Employees

Meet Christelle, Senior Quality Manager in Malta

Meet Lorena, Senior QA Associate in London, UK

Meet Gary, Quality Research Manager in Singapore

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Join Our Talent Community