This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

The Role

We have an exciting opportunity for a Quality Manager to join our RAQA team at Baxter. Reporting to the Head of QARA ANZ you will work to understand, implement, maintain, and continually improve the efficiency of the Baxter Quality Management System.

With a key focus on Quality leadership, your role will include working on setting up systems and processes ensuring regulatory compliance, as per applicable regulation and standard. As the Quality Management Representative, you will ensure that measurable quality objectives and goals are consistent with the quality policy. You will lead, manage and develop a team of RAQA Specialists, while partnering closely with key internal and external stakeholder across the Baxter organisation.

If you are a passionate quality professional looking to make a significant impact on patient 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:

• Ensure QMS requirements are effectively established and maintained

• Delegate authority to personnel responsible for various aspects of the QMS

• Report on the performance of the QMS and any need for improvement to the highest level

• Ensure field surveillance activities are executed

• Ensure product safety risks are effectively evaluated, managed, communicated, and documented

• Maintain the integrity of the QMS when changes to the QMS are planned and implemented

• Promote the awareness of regulatory and customer requirements throughout the organization

• Approve or reject components, containers, closures, in-process materials, packaging material, labeling, and final products

• Ensure and maintain the GMP compliance for Pharma

• Review production/quality records to ensure that exceptions have been appropriately addressed

• Perform and Lead Internal Auditing

• Prepare and lead management review meetings

• Lead and coordinate Supplier Quality activities

• Manage and lead nonconformance and CAPA.

Key Requirements of the role include:

• Tertiary degree in Science or related fields

• Minimum of 10 years’ experience in Quality, Manufacturing or related fields in the medical products industry

• 7 or more years management experience, preferably in a global organization

• Strong understanding and working knowledge of FDA, TGA (PIC/S) and Medical Device Regulations, Application of Good Manufacturing Practices

• Comprehension of design methodology, product configuration and complex manufacturing processes.

• Ability to work under strict deadlines and changing priorities with minimal supervision.

• Project management experience is highly regarded

• Highly developed interpersonal effectiveness and relationship-building abilities

• Collaborative approach and ability to work well with others.

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

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