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QARA Specialist, 6 Months Fixed term

Req # 205740 Location Old Toongabbie, New South Wales, Australia Job Category Quality Date posted 07/31/2026
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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

QARA Specialist, 6 Months Fixed term

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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. 

The Role

We have an exciting opportunity for a QARA Specialist to join our QARA team at Baxter for a 6-month fixed-term role. Reporting to the Head of QARA – ANZ, you will work collaboratively with the Operations, Quality , Regulatory and Supply Chain teams, enabling the timely delivery of fully compliant products and processes in line with the ANZ Commercial Business Plan.

With a key focus on regulatory and quality, your role will support the effective management of Quality Management System, including management reviews, product complaints, nonconforming products, Field Actions, CAPA, internal audits, quality records control, training and supplier controls, to maintain ISO 9001 certification. If you are a passionate regulatory and quality professional looking to make a meaningful impact on patients’ lives, we’d love to hear from you!

This is where you can do your best work. Where your purpose accelerates our mission.

Key Responsibilities

Quality Assurance

  • Support the effective operation and continual improvement of the Quality Management System (QMS) in accordance with applicable procedures, standards and certification requirements

  • Coordinate quality activities including nonconforming products, CAPA, quality records, training, supplier controls and management review inputs

  • Support internal and external audits, including audit preparation, response coordination and follow up of corrective actions

  • Drive complaint and feedback handling activities, ensuring investigations are completed, documented and escalated appropriately

  • Support product quality investigations, risk assessments and quality decision-making activities

  • Coordinate Field Actions and post-market activities, including reconciliation, effectiveness checks and closure activities

  • Review quality impacts associated with product, process, supplier and manufacturing changes, ensuring appropriate controls and documentation are implemented

  • Partner with Operations, Supply Chain, Commercial and other stakeholders to identify compliance risks and implement effective corrective actions.

Regulatory Affairs (Medical Devices)

  • Provide regulatory support for Baxter's medical device portfolio across Australia and New Zealand

  • Maintain regulatory authorisations and registrations, including ARTG entries, manufacturer evidence, Medsafe WAND records and associated regulatory databases

  • Prepare and coordinate regulatory submissions, notifications and responses to regulatory authority requests within required timeframes

  • Assess regulatory impacts associated with product, manufacturing, supplier, labelling and design changes

  • Support post-market regulatory activities, including vigilance reporting and regulatory notifications where required

  • Review and approve medical device labelling, promotional and advertising materials, tender documentation and customer-facing communications to ensure regulatory compliance

  • Monitor changes to applicable regulations, standards and guidance documents and communicate impacts to relevant stakeholders

  • Act as a key point of contact for regulatory enquiries from internal and external stakeholders.

Key Requirements:

  • Tertiary qualification in Science, Engineering, Quality, Regulatory Affairs or a related discipline.

  • Experience in Quality Assurance and/or Regulatory Affairs within the medical device, healthcare or other regulated industry.

  • Working knowledge of Quality Management Systems, including complaints, CAPA, audits, document control and supplier quality processes.

  • Understanding of Australian and New Zealand medical device regulatory requirements.

  • Knowledge of ISO 9001 and ISO 13485 requirements is highly regarded.

  • Strong organisational, communication, and stakeholder management skills.

  • Ability to manage multiple priorities and work effectively in a collaborative environment.

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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 P O Box 88, One Baxter Drive
Old Toongabbie NSW 2146
Australia 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.”

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