About the Company:

An exciting opportunity has arisen for an experienced QA Engineer or QA Specialist (Senior level) to join Atomo Diagnostics. Atomo designs and produces patented in diagnostic platforms supplied globally to partner companies, as well as our own HIV Self Tests with certification already secured from the Australian TGA, CE (Europe), and WHO Pre-Qualification.

About the Role:

This is a permanent full-time role based in Sydney, offering the chance to work in a collaborative international QA/RA team with colleagues in both Australia and with Atomo’s operations team in South Africa. You will play a key role in maintaining and improving a certified ISO 13485 Quality Management System (QMS) and supporting a range of regulatory and R&D initiatives.

Key responsibilities for this role: 

• Maintain key QMS processes: Document Control, CAPAs, NCRs, and Complaints
• Act as Quality lead for external supplier and regulatory audits (ISO 13485)
• Oversee batch release activities in a GMP-compliant environment
• Lead QMS improvement initiatives and contribute to post-audit CAPA investigations
• Collaborate with R&D and Marketing teams to support QA for development projects
• Review technical documentation (e.g. validation reports, shelf-life studies)
• Develop and deliver quality/SOP training materials

About You

This is a fantastic opportunity for someone to utilise their quality experience in the Diagnostics or Medical device industry. Ideally, you will have a medical science, biochemistry or biomedical engineering background and relevant industry experience.

• A bachelor’s degree in biomedical engineering, Chemistry, Medical Science, or a related discipline
• Minimum 4 years of recent, relevant QA experience in the medical device or diagnostics sector
• In-depth understanding and practical implementation of ISO 13485
• Internal audit certification preferred
• Experience in GMP environments and batch release processes
• Strong knowledge of supplier quality management and audit processes
• Excellent communication and documentation skills
• High attention to detail with the ability to work independently and collaboratively
• Proficiency in Microsoft Office; experience with eQMS platforms an advantage
• Supervisory experience or ambition to grow into a leadership role welcomed

Benefits

• Permanent position with long-term career growth potential
• Work on high-impact diagnostic products used internationally
• Join a supportive and knowledgeable QA/RA team with global reach
• Be part of an organisation focused on improving access to diagnostics worldwide

How to Apply: 

Apply now to Atomo to take the next step in your QA career and contribute to improving global health outcomes from Sydney, Australia. Send your resume to hr@atomodiagnostics.com