Company Description

At Genea Biomedx we innovate fertility technologies to streamline lab workflow and transform fertility treatments. Our goal is to leverage our extensive expertise to deliver precise, accessible technology that significantly improves both performance and patient results

Genea Biomedx is designing and manufacturing IVF Media, devices and technology that aims to simplify, standardize and automate fertility treatment. We offer potential employees the chance to join our team creating cutting-edge Media and medical devices for the IVF industry.

We are currently seeking a microbiology, biotech, pharmaceutical science, medical science degree-qualified candidate with previous laboratory, engineering and quality assurance experience in medical devices, pharmaceuticals or biotechnology manufacturing.

The preferred candidate will possess a sound working knowledge of ISO 13485, with experience maintaining and working within a quality management system. The role will require proficient technical written skills with operating procedures, work instructions, protocols and reporting. The successful candidate will also be responsible for investigating and resolving non-conformances.

This is a great chance to continue to build your practical skills and advance your career with a fast-growing business.

Working and closely supported by our team, your responsibilities include:

- Driving product quality excellence by collaborating with cross-functional teams to monitor, maintain and continuously improve quality outcomes.
- Supporting and enhancing Quality Control (QC) and Quality Assurance (QA) activities across manufacturing and operational processes.
- Analysing quality and operational data to identify trends, insights and opportunities for improvement.
- Developing, implementing and optimising QA, QC and manufacturing processes to support business growth and compliance.
- Mentoring and supporting the development of team members, fostering a culture of quality and continuous improvement.
- Managing and maintaining the Quality Management System (QMS), ensuring alignment with regulatory and business requirements.
- Investigating product complaints, quality issues and non-conformances, driving effective corrective and preventive actions (CAPAs).
- Oversee change control and quality improvement initiatives, ensuring robust risk assessment and implementation.
- Plan and conduct internal,



supplier and external audits, supporting ongoing compliance and quality performance.
- Manage supplier quality programs, including supplier evaluations, approvals and performance reviews.
- Create, maintain and improve quality documentation, including SOPs, work instructions, policies, forms and templates.
- Provide QA oversight for facilities, equipment and asset management activities while promoting adherence to quality standards.
- Deliver training and guidance on QMS, QA and compliance requirements to support organisational capability.
- Lead qualification and validation programs for facilities, equipment and processes, from protocol development through to reporting and audit presentation, including technology and process transfer activities.
- Ensure timely product release by reviewing and approving batch documentation, Certificates of Analysis, inwards goods and market-release requirements in line with production schedules, and maintaining accurate batch record storage.
- Reviewing and maintaining manufacturing, facilities, inventory management and shipping documentation, and supporting Document Control processes.
- Liaising with Genea Biomedx colleagues across other sites to share best practice and ensure consistent quality standards globally.
- Contributing to the QMS management review process to drive continuous improvement.
- Providing input into project planning, assessing the impact of new initiatives on the QA/QMS scope and associated procedures.

About the Position: We are seeking a driven, proactive team player to join the Genea Biomedx Quality Assurance team who:

- This is a hybrid role, with a requirement to work two days onsite (321 Kent St, Sydney), and the rest of the week remotely.
- Demonstrates their Initiative, accuracy and attention to detail.
- Possesses an excellent work ethic with effective organisational skills.
- Is able to participate as an active team member and also work independently.




- Able to thrive in a fast-paced environment while maintaining high-quality standards and meeting frequent deadlines.
- Self-motivated to continuously develop technical and soft skills
- Excels at communicating complex information clearly and concisely including verbal and written communications.

Qualifications To be successful in this role you will be a qualified Scientist or Engineer ideally with some professional experience working in a laboratory. You will have a genuine interest in working in the quality environment and enjoy working flexibly as part of a team. Qualifications & Attributes:

As a Quality Assurance Associate within Genea Biomedx, the successful applicant will bring the following attributes to the role:

- Tertiary science or engineering degree (Microbiology, Biotech, Pharmaceutical Science, Medical Science or Engineering)
- Experience in a Quality Assurance role within medical devices, pharmaceuticals or biotechnology manufacturing
- Working knowledge of ISO 13485 and experience maintaining a Quality Management System (QMS)
- Proficient in Microsoft Office (Word, Excel, PowerPoint) and confident using QMS/ERP systems
- Previous work experience in a GMP/GLP-regulated laboratory will be highly regarded
- Proven ability to work accurately and efficiently under time pressure
- Continuous improvement mindset to streamline processes
- Flexibility to take on additional responsibilities as required
- Demonstrated hands-on experience with aseptic techniques and equipment
- Meticulous record-keeping habits and compliance mindset
- Keen problem-solving aptitude and willingness to learn
- Able to work independently and collaboratively, while following directives where necessary

Our staff enjoy working at Genea Biomedx for several key reasons; flexibility, development opportunities, and fulfilment of working somewhere that truly makes a difference to people's lives. What's in it for you?

- Genuine opportunities for career growth and career development
- Project and spot bonus schemes
- Join our social club
- We are a certified family-friendly workplace

If you’re ready to bring your QA expertise to a business that’s transforming fertility treatment worldwide, we’d love to hear from you. To apply, please click on the apply below or if you have any questions, please email our HR team at [email protected]

📌 Quality Assurance Associate (Sydney)
🏢 Genea Biomedx
📍 Sydney