About the Company: An exciting opportunity has arisen for an experienced QA Engineer or QA Specialist (Senior level) to join a growing and innovative Australian IVD manufacturer. This company designs and produces patented in vitro diagnostic (IVD) cassettes supplied globally to major diagnostics companies, as well as its brands of HIV Self Tests with certifications 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 South Africa. You'll 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 take the next step in your QA career and contribute to improving global health outcomes from Sydney, Australia.
KE Select is an Australian-based, leading Scientific & Medical Recruitment Partner for many organisations within the Life Science, Medical, Clinical, Hospital and Healthcare space. We specialise in Permanent and Temporary recruitment across Australia and New Zealand. If you are a candidate looking for a new role or a company looking for an industry-specific recruitment firm, please visit our website to find out more. www.keselect.com
