- Experience
- 5+ yrs
- Salary
- —
- Openings
- 1
- Posted
- 5時間前
- Work mode
- Work from home
- Education
- Bachelor's degree in Bioscience, Biotechnology, or related field
- Eligibility
- Applicants must be locally hired residents within Australia.
- Resume
- Required to apply
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Job description
About the Role
Join a leading global standards and business improvement organization committed to positive societal and environmental impact. This opportunity involves working as a Medical Device Auditor, also referred to as a Client Manager, supporting medical device manufacturers across Australia and New Zealand from a home-based location in New South Wales, Australia.
Primary Responsibilities
- Complete extensive specialized training including ISO13485 Lead Auditor certification, Medical Device Single Audit Programme (MDSAP), and Medical Device Regulation (MDR).
- Conduct audits of ISO13485 quality management systems and associated regulatory compliance for medical devices at client sites or remotely.
- Travel frequently across Australia and New Zealand, with occasional international travel required.
- Prepare detailed audit reports and present findings to clients.
Qualifications and Experience
- Pursued a degree in Bioscience, Biotechnology, or a closely related field with modules specifically related to implantable medical devices.
- Possess at least five years of direct responsibility in the design and development or research and development of various medical devices.
- Have demonstrated expertise in in-vitro diagnostic medical devices, including research, design, manufacturing, or testing of reagents, instruments, and their interfaces.
- Applicants must be locally hired in Australia.
About the Employer
The company has over 100 years of experience providing industry-leading standards and certifications worldwide. With clients in 195 countries and partnerships with industry experts, governments, and consumer groups, it fosters trust and growth across diverse sectors such as healthcare, automotive, aerospace, and more. The organization upholds the values of client-centricity, agility, and collaboration to contribute to sustainable and trustworthy business practices globally.
Diversity, Equity, and Inclusion
The employer is committed to equal opportunity and nurturing a diverse and inclusive workplace environment.
Minimum education
Bachelor's Degree