Quality Manager

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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 Manager

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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.

Your role at Baxter:

You as Quality Manager are responsible for leading quality control efforts within the facility. These efforts support manufacturing operations and ensure compliance with medical device, pharmaceutical, combination-product, and solutions regulations. This role serves as the main QA representative on the shop floor. It offers real-time quality oversight, decision-making, and works with Operations to ensure product quality, safeguarding patients, and regulatory compliance.

The role has accountability for quality assurance activities on the production floor, batch review and release, nonconformance management, investigations, CAPA execution, and complaint handling, and acts as a key Quality interface for site leadership and regulatory inspections.

What you will be doing:

Provide a strong QA presence on the manufacturing floor. Ensure manufacturing activities follow approved procedures, batch records, and applicable legal and industry standards for solutions, medical devices, or pharmaceutical products.
Support real-time quality decision-making during manufacturing, including line clearances, process adherence, identification of deviations, and resolution of quality issues.
Act as the primary Quality partner concern point for shop-floor issues that may impact product quality, compliance, or patient safety.
Own or supervise batch record review, disposition, and product release activities, ensuring documentation is complete, accurate, and compliant prior to release.
Make independent, risk-based batch release decisions in alignment with quality standards, site procedures, and regulatory expectations.
Ensure timely batch release while balancing supply continuity and compliance requirements and support interactions with QP or responsible release functions where applicable.
Lead and handle nonconformances, deviations, and quality events, ensuring issues are accurately detailed, investigated, and closed within defined timelines.
Drive high-quality root cause analysis and ensure corrective and preventive actions are appropriate, effective, and balanced.
Ensure CAPAs address systemic issues and actively supervise efficiency to prevent recurrence.
Lead or offer QA supervision of manufacturing and quality investigations, ensuring investigations are scientifically sound, risk-based, and meet regulatory expectations.
Review and approve investigation documentation, impact assessments, conclusions, and links to batch disposition and CAPAs.
Ensure investigation outcomes are clearly supported, traceable, and inspection ready.
Deliver QA oversight for product complaints, including complaint evaluation, investigation, trending, and regulatory impact assessment as applicable.
Ensure complaints are assessed regarding their effect on product quality and patient risk, and that documentation meets internal and regulatory requirements.
Partner with Regulatory Affairs and site team members to support timely complaint responses and reporting obligations where required.
Support and actively participate in regulatory inspections, internal audits, and customer audits at the site.
Ensure manufacturing-related quality documentation, including batch records, deviations, investigations, CAPAs, and complaints, is inspection ready.
Give to responses to audit findings and ensure sustained remediation of identified issues.
Act as a crucial Quality partner to Manufacturing, Operations, Engineering, Supply Chain, and Site Leadership.
Provide coaching, mentorship, and training to manufacturing teams on Quality expectations, compliance requirements, and right-first-time behaviors.
Promote a strong culture of quality ownership, accountability, and continuous improvement while operating in a fast-paced, regulated manufacturing environment.
Call out quality and compliance risks appropriately to site and Quality leadership.

What will you bring?

Bachelor’s degree experience in science, Engineering, or equivalent
5–8+ years of Quality Assurance experience in regulated manufacturing environments (medical devices, pharmaceuticals, or solutions)
Hands-on experience with QA on the floor, batch release, deviations, investigations, CAPA, and complaints
Strong understanding of applicable quality systems and legal standards
Experience supporting audits and compliance reviews

Preferred

Experience with FDA QMSR / 21 CFR 820, ISO 13485, 21 CFR 210/211, EU GMP, or combination products
Prior site-level Quality leadership experience in manufacturing environments
Exposure to continuous improvement or operational quality initiatives

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 Manager

Overview

Success Profile

Quality Manager

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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