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Form of workAbout the Role
Our Quality Assurance and Regulatory Affairs (QARA) team are on the hunt for a QARA Associate to join our team on a 8 month, full time, fixed term contract. In this role you will be responsible for leading post market quality actions whilst also supporting internal stakeholders to maintain regulatory compliance.
The role will work closely with the wider Quality and Regulatory team, Olympus customers, manufacturers and internal stakeholders. As such your strong communication skills and ability to liaise with customers, manufacturers, and internal departments will be critical to your success.
Key Responsibilities:
- Leadership from initiation through to implementation of all OAZ field corrective actions and quality holds.
- Supporting the wider QARA team in execution of Field Corrective Actions including product rework.
- Management of non TGA related regulatory and legislation requirements and reporting including chemical handling and radiating equipment.
- Regulatory oversight of promotional materials ensuring compliance with relevant legislation and codes of practice.
- Reporting of metrics and maintenance of the QARA reporting dashboards.
- Maintenance of QARA documentation, including the creation, support, review and publication of new or revised QMS documentation.
- Supporting product registration, product change control reviews and pre-launch activities as required.
- Assist in local and global QARA improvement initiatives and projects.
- Completion of corrective and preventative actions and nonconformances for processes within the QARA Associate's area of responsibility.
About Olympus:
Our purpose at Olympus is to make peoples' lives healthier, safer and more fulfilling. We do this through innovation. As a technology pioneer, we design and deliver solutions across our Medical division that makes a positive contribution to society.
Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
Our commitment to customers and our social responsibility is the cornerstone of everything we do.
Why work at Olympus?
At Olympus, we are dedicated to fostering a high performing culture, a collaborative environment, and enabling everyone to shine. Our common values of Patient Focus, Integrity, Innovation, Impact, and Empathy form the foundation of our culture and guide our behaviour, where our people feel like they are making a difference every single day.
Not only will you benefit from a meaningful, rewarding and challenging career, you will have access to a range of benefits:
- A competitive salary package;
- Learning on demand;
- Flexible work arrangements (work from home, flexible hours, purchase additional leave);
- Health and Wellbeing initiatives (Corporate Games, Run 4 Kids, Free Bowel Cancer Screening tests, RUOK Day, and EAP);
- Home office allowance available for eligible roles upon commencement;
- Reward and Recognition Program 'Shining Stars';
- Dress for your day;
- Social events (Strategy forums, Annual Awards, and Christmas parties).
What we are looking for:
- Tertiary qualifications in scientific, medical, legal or related discipline
- Knowledge of ISO 9001 or ISO 13485 desirable
- Must possess exceptional project management abilities including clear communication skills when liaising with customers, manufacturers, and internal departments.
- Self-motivated and able to take initiative.
- Excellent attention to detail.
- Process, analysis and problem-solving skills would be highly regarded.
- Strong reporting and MS Office skills.
- Experience with SAP, Salesforce, Power BI and Office365 would be highly regarded.
- Demonstrated commitment to business improvement.
Apply Now:
To submit your interest in this opportunity, select "Apply for this job".
In the meantime, follow us on:
- LinkedIn - Olympus Australia and New Zealand
- Company website - www.olympus.com.au
No Agency assistance required at this time.
Olympus Australia is an Equal Opportunity Employer
