Senior Quality Specialist, Technical Services at Baxter
Old Toongabbie, New South Wales, Australia -
Full Time


Start Date

Immediate

Expiry Date

18 Oct, 25

Salary

0.0

Posted On

19 Jul, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Requirements, Quality Processes, Medical Devices

Industry

Other Industry

Description

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.

KEY REQUIREMENTS

  • Tertiary degree in Science/Biomedical Engineering or related fields
  • Proven experience in quality assurance within a technical services environment
  • Strong understanding of regulatory requirements and quality systems in Australia and New Zealand
  • Prior experience within Medical Devices or Medical Capital is highly desirable
  • Outstanding communication and collaboration skills
  • Ability to successfully implement quality processes and procedures
  • Proven track record of managing and leading projects to a flawless conclusion.
Responsibilities

THE ROLE

We are seeking a Senior Quality Specialist to join our Technical Services team at Baxter. As a key member of our team, you will play a critical role in ensuring processes and procedures for Technical Service Operations in Australia and New Zealand are in compliance to regulatory requirements and in line with Corporate Quality Manual and Global Service requirements.
You will actively participate in the design, implementation and/or maintenance of the quality processes in the field service (technical) operations and service center operations, while maintaining a strong relationship with the Global Services team , and relevant stakeholders across the broader Baxter business.
This role will be based at our Old Toongabbie office with time spent at the Technical Services Depot.

RESPONSIBILITIES

  • Provide quality support to field service operations in Australia and New Zealand
  • Offer quality support to service center operations in these regions
  • Serve as the Local Process Owner for Global Services Quality Systems in Australia and New Zealand, including documentation, procedures, training, internal and external audits, CAPA, non-conformities, and post-marketing surveillance activities
  • Coordinate supplier qualification, validation processes (IQ, OQ, PQ protocols), change control processes, and risk assessments
  • Ensure compliance in processes such as device release, labeling, storage areas, calibration, decontamination, equipment validations, repair, PM, and spare parts management
  • Monitor and act on quality critical metrics using TS systems
  • Act as the Local QMR for Technical Service in Australia and New Zealand
  • Support and/or lead local or regional Service QA and Operational projects and initiatives as required.
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