Quality Assurance Specialist

We’re looking for a self-motivated and efficient individual to have overall accountability for our Quality Management System (QMS) and activities across ANZ legal entitles at Cardinal Health. The successful candidate will have a passion for ensuring the quality and safety of our products and services, while ensuring the ongoing suitability, adequacy and effectiveness of the ANZ QMS and compliance with applicable regulations and standards. Other key responsibilities will include:

• Conducting Internal Audits to ensure business compliance to ISO 13485, Corporate and ANZ Policies and Procedures.
• Responsible for all Post Market and Commercial Quality Operations Activities such as Complaint Handling, Vigilance Reporting, Holds, Field Actions, Customer Feedback, Documentation Control & Training for Cardinal Health ANZ.
• Supplier Management; evaluation, selection, approval, maintenance and monitoring of Australia and New Zealand (ANZ) suppliers and service providers.
• Completing CAPAs and Non-conformance Reports.
• Communicating effectively cross-functionally and supporting requests from both internal and external customers and stakeholders.
• Lead and support continuous improvement initiatives as required by the business.

 What We Offer:

• A Purpose-Driven Culture: Thrive in an environment that values making a positive impact on our customers and communities. We think of ourselves as the business behind healthcare because we believe “time and patients matter”. We’re an essential link that allows healthcare providers to create efficient operations and deliver quality care and improved patient outcomes.
• We offer flexible hybrid working between your home (3 days) and our North Sydney office location (2 days).
• Competitive Compensation & Benefits: Attractive salary and benefits that reflect your skills and contributions.
• You will report to the Senior Manager QRA, an inspiring and experienced leader who encourages fresh, innovative ideas and personal development.

Experience and skills we are looking for:

• 2-4 years of experience in quality role, preferred
• Bachelor's degree in related field, or equivalent work experience, preferred
• Knowledge in the Australian and New Zealand Post Market Requirements
• Communication skills and an ability to write logically.
• Understanding of ISO 13495:2016 Medical devices — Quality management systems and the TGA post market regulations.
• Ability to prioritize and take actions systematically while making timely decisions.
• Ability to make risk-based decisions.
• Ability to write explanations and justification that are supported with data in a clear and convincing manner, review various types of documentation for regulatory acceptability.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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