Quality Associate III

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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 III

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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.

Summary: This role is responsible for process related to Postmarket Surveillance Plans, Postmarket Surveillance Reports and Periodic Safety Update Reports (PSUR), and for oversight of activities associated with these documents. This role is also responsible for maintaining schedule, and for ensuring completion of China and Health Canada Annual Product Reports. Ability to handle multiple projects and demonstrate effectiveness in task completion, decision-making, empowerment of others, problem solving and team leadership. A functional understanding of FDA, ISO and Baxter Quality systems is also required.

Essential Duties & Responsibilities:

Serves as a Subject Matter Expert for processes related to EU required Postmarket Surveillance Plans, Postmarket Surveillance Reports, Periodic Safety Update Reports (PSUR), and China and Health Canada Annual Product Reports.
Maintaining processes and procedures, including procedural updates and alignment with regional and global regulatory requirement
Establishing and managing schedule (the Repository Master List) to ensure timely completion of activities and the Postmarket Surveillance documents (PMSP, PMSR, PSUR, China and Health Canada Annual Product Reports), including oversight, tracking, monitoring, and coordination with stakeholders
Leading ongoing daily departmental activities for areas of direct responsibility and assist other Quality areas in the successful performance of these activities
Supporting management reviews with providing data and performance related to Postmarket Surveillance documents
May interface with regulatory agents or internal auditors
May perform other activities within Quality as assigned

Qualifications

Ability to effectively communicate (verbal and written) across different functions and across multiple levels within the organization
Good project management skills
Strong understanding of international medical device regulations
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
Collaboration and Teamwork
Detail Oriented
Strong technical writing skills

Education and/or Experience

Bachelor’s degree (Science or Engineering preferred)
5-8 years of experience in Quality/Regulatory Affairs, or related field preferred in the medical products industry
Experience with driving process improvement initiatives and projects

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 minimum salary for this positionis €36,800.00 annually.Your initial pay could be at the minimum or higher based on location, skills and expertise, experience, and other relevant factors, all of which are subject to change. This position may also be eligible for competitive benefits, discretionary bonuses, 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.

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

Explore this location A47 Marsa Industrial Estate
Marsa
MRS3000
Malta Explore This Location

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 III

Overview

Success Profile

Quality Associate III

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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