Genetic Signatures improves patient care and outcomes by developing innovative diagnostic technologies which simplify molecular pathology.

We are an Australian based manufacturer selling into leading pathology laboratories in Australia, and distributing worldwide, and are looking to expand our diverse, supportive and talented team.

We currently seeking a solution focused Senior Quality Assurance Manager (QMR), to join our Regulatory and Quality team. Reporting to the Global Regulatory and Quality Manager this standalone role leads the development, implementation, and maintenance of the quality management system. The role is also responsible for overseeing quality controls and process checks to ensure GS delivers high-quality molecular diagnostic products that support better healthcare outcomes for patients worldwide.

In this role you will be responsible for:

• Leading the development, implementation, and continual improvement of the Quality Management System (QMS) in alignment with ISO 13485 and regulatory requirements.
• Acting as the subject matter expert for ISO 13485 and provide quality strategical guidance across the business.
• Coordinating with cross-functional teams to define and maintain QMS processes for their departments.
• Partnering with the Global Regulatory and Quality Manager to ensure product development complies with quality and regulatory standards.
• Liaise with Production and QC to support compliance in manufacturing, quality control, and documentation practices.
• Manage and improve the electronic Quality Management System (eQMS), ensuring records are maintained and accessible.
• Lead internal and external audits, including planning, hosting, and ensuring timely closure of audit findings.
• Coordinate supplier audits and monitor supplier quality performance in collaboration with Procurement.
• Oversee nonconformance and CAPA processes to ensure timely resolution and drive continual improvement.
• Monitor and report on QMS performance metrics, providing actionable insights for process enhancement.
• Analyse quality data, including complaints and audit trends, to identify areas for improvement.
• Support post-market surveillance activities and ensure findings are fed back into the QMS.
• Ensure integration of risk management activities in line with ISO 14971 throughout product and process lifecycles.
• Contribute to setting and reviewing quality objectives and participate in annual management reviews.
• Coordinate training and competency programs to ensure staff compliance with QMS requirements.

To be successful as our Senior Quality Assurance Manager, you will bring experience in:

• Managing or implementing quality systems for IVDs or other regulated medical products
• ISO 13485 and relevant regulatory frameworks (e.g. IVDR, FDA QSR)
• Internal and external audits, including regulatory and certification body inspections
• CAPA, nonconformance handling, and supplier quality management
• Document control, change management, and training systems
• Analytical thinking and a process-driven, solution-oriented mindset
• Clear, confident written and verbal communication
• Working independently and collaboratively within cross-functional teams

You will also hold a bachelor’s degree in science, engineering, or a related field (a master’s or PhD is advantageous).

Experience in the diagnostics or life sciences sectors, particularly in the validation or launch of regulated products, will be highly regarded. Knowledge of molecular diagnostics or the methylation field is an additional advantage.

Genetic Signatures Ltd is committed to providing equal employment opportunities, we thrive on the diversity of thought that comes to us through our workforce and encourage anyone possessing the talent and drive to better health care for their community to apply.

The successful applicant will be rewarded with a competitive remuneration package, commensurate with experience.

If this sounds like your next career opportunity and you want to make a difference to healthcare outcomes, apply now, we can’t wait to hear from you!

Please apply with a cover letter and CV below or via Seek. Enquiries can be made via email at [email protected]. All applications will be treated in the strictest confidence. Please note that due to the expected large number of applications, only those who are short-listed will be contacted for an initial interview.

Genetic Signatures Ltd is committed to providing equal employment opportunities, we thrive on the diversity of thought present in our workforce and encourage anyone possessing the talent and drive to better health care for their community to apply. All qualified applicants will receive consideration for employment without regard to race, colour, religion, national origin, gender, age, sexual orientation, gender identity, disability, status as a Veteran or other protected classification