Quality Engineer at Cardinal Health in Beresfield, Australia

About Cardinal Health

Cardinal Health is a global leader in the healthcare supply chain, delivering critical products and services that improve patient outcomes worldwide. With operations spanning manufacturing, distribution, and innovative medical solutions, Cardinal Health touches every aspect of healthcare. In Australia, our Beresfield facility plays a pivotal role in producing high-quality medical devices that meet stringent regulatory standards. We pride ourselves on fostering an inclusive workplace where diversity of thought, experience, and background drives better solutions for customers. As an Equal Opportunity Employer, Cardinal Health celebrates differences and ensures every employee can be their authentic self.

Role Overview

The Quality Engineer position at Cardinal Health in Beresfield, Australia, is a key role within our Quality Engineering team. This full-time position focuses on leading quality assurance for medical device products and processes. You will drive compliance with ISO 13485 and 21 CFR 820 regulations, support new product development, and ensure released products meet the highest standards. Working cross-functionally, you'll collaborate with Regulatory, Medical Affairs, R&D, Manufacturing, Suppliers, Audit, CAPA, and Program Management teams. This role offers the chance to apply comprehensive knowledge to complex projects, develop innovative solutions, and contribute to policies and procedures.

Key Responsibilities

As a Quality Engineer, your impact will be felt across the organization through hands-on leadership in quality and compliance.

• Apply deep expertise in concepts, principles, and technical capabilities to manage varied tasks and large-scope projects.
• Interpret regulations like ISO 13485 and 21 CFR 820, conduct gap analyses, and lead implementation of improvements.
• Drive continuous improvement initiatives, data analysis, and system conformance to ensure finished goods meet specifications.
• Support cross-functional teams in Regulatory, R&D, Manufacturing, Supplier management, Audits, CAPA, and Program Management.
• Execute risk management activities, including Risk Management Plans, Hazard Identification, Risk Analysis Charts, and Reports.
• Develop innovative technical solutions to difficult problems, aligning with Cardinal Health's objectives.
• Work independently on new projects with general guidance, while mentoring less experienced colleagues.

Qualifications & Requirements

Cardinal Health seeks candidates with proven expertise in quality engineering for medical devices.

• 4-8 years of relevant experience, preferably in healthcare or medical devices.
• Bachelor's degree in a related field such as engineering, quality assurance, or equivalent work experience.
• Strong understanding of ISO 13485, 21 CFR 820, and risk management standards.
• Experience with CAPA, audits, gap analysis, and cross-functional collaboration.
• Ability to handle complex projects independently and innovate under general guidance.

We encourage applications from back-to-work candidates, people with disabilities, those without college degrees, and Veterans.

Benefits & Perks

Joining Cardinal Health means accessing a comprehensive benefits package tailored to support your professional and personal life.

• Competitive salary estimated at AUD 65,000 - 95,000 annually, based on healthcare sector rates in Australia.
• Inclusive culture promoting diversity, equity, and belonging.
• Opportunities for career advancement and mentoring roles.
• Supportive policies for work-life balance in a global organization.
• Equal employment opportunities without regard to race, religion, disability, or other protected statuses.

Career Growth

At Cardinal Health, Quality Engineers are positioned for long-term success. This role involves working on complex, large-scope projects that build expertise in medical device quality. You'll receive general guidance on new initiatives but operate independently, fostering leadership skills. Opportunities to contribute to policy development and mentor juniors pave the way for advancement into senior quality roles or management. Our global network provides exposure to cutting-edge healthcare innovations, ensuring your career evolves with industry standards.

Why Join Us

Cardinal Health's Beresfield team is at the heart of Australia's medical device manufacturing. By joining us, you contribute to products that save lives and improve healthcare delivery. Our commitment to prevention-based methodologies, regulatory excellence, and continuous improvement creates a dynamic environment. Benefit from a premium workplace that values innovation, inclusivity, and employee growth. In Beresfield, enjoy proximity to vibrant communities while advancing your career in a stable, forward-thinking company.

Role FAQs

What experience is required for the Quality Engineer role?

4-8 years of experience in quality engineering, preferably with medical devices and regulations like ISO 13485.

Is a degree necessary?

A Bachelor's degree in a related field is preferred, but equivalent work experience is considered.

What is the work environment like?

Cross-functional, collaborative, with a focus on independent project work and innovation in a supportive, inclusive setting.

How does Cardinal Health support diversity?

We are an Equal Opportunity Employer, encouraging applications from diverse backgrounds including Veterans and people with disabilities.

What is the estimated salary range?

AUD 65,000 - 95,000 yearly, with potential for more based on experience.