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 fora QARASpecialist to join ourQARAteam at Baxter. Reporting to theHead of QARA –ANZ,you will work collaboratively with the Operations,Quality,Regulatoryand Supply Chain teams, enablingthetimely delivery of fully compliant products and processesin linewiththe ANZ Commercial Business Plan.
With aprimaryfocus onQuality, thisqualityrole willsupporttheeffective management ofQuality ManagementSystem,with particular emphasis on thedocumentationincludingmanagementsystem andtraining.You will help ensure quality documents, records and training activities are maintained accurately, completed on time and aligned with applicable regulatory and business requirements. In addition, you will assist the QARA team with other quality activities as needed, including CAPA, internal and external audits, Field Actions (FAs),complaints, nonconforming products,supplier controlsand other quality processes that support compliance and continuous improvement
If you are a passionatequalityprofessional looking to make ameaningfulimpact onpatients’lives, we’d love to hear from you!
Key Responsibilities
Manageand support Quality Management Systemactivities, with a key focus on documentation management and training managementwith minimal supervision
Maintain, update and control quality documentation, including procedures, forms, records and related quality documents, ensuring accuracy, version control, timely review and compliance with applicable requirements
Coordinate training management activities, including trainingassignments, completion tracking, record maintenance and follow-up with stakeholders to support timely and compliant training outcomes
Support document lifecycle processes, including document creation, review, approval, effective release, periodic review, archival and retrieval, in line with internal proceduresand systems
Partner with cross-functional teams to promote compliant documentation and training practices and provide guidance on quality process requirements where required.
AssistQARAteammemberswithotheroperationQualityactivities as needed,includingCAPA, internal and external audits, Field Actions (FAs),complaints, nonconforming products,management reviews,Field Actions (FAs),quality records control,supplier controlsand other activities requiredto maintaincompliance withISO 9001and applicable quality system requirements
Act as apoint ofcontact forenquiries relatingtodocumentation and training management .
Key Requirements
Tertiary degree in Science or related fields
5or moreyears’experience working inaQualityenvironment within themedicaldevicesPharmaindustry is desirable
Good understanding and working knowledge of Australian,New Zealandand European UnionQualityregulations(e.g. PICs, EudraLex , other GMP regulations)
Project management experience is highly regarded
Highly developed interpersonal effectiveness and relationship-building abilities
Collaborative approach and ability to work well with others.
#li-baxgen
#LI-JB1
#ind-aus
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
For nearly a century, we have delivered on our commitment to saving and sustaining the lives of patients, working alongside clinicians and providers around the world. We believe every person — regardless of who they are or where they are from — deserves a chance to live a healthy life, free from illness and full of possibility. At the intersection of progress and purpose is where we are redefining what it means to be a global medtech leader. It is where we are relentlessly pursuing healthcare transformation, fueled by our compassion for patients and providers and the challenges they face. It is where bold ideas meet the promise for meaningful change in the world around us. We are there, at every step of the journey, to help clinicians deliver the best care possible.
