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 are currently looking for an experienced and proactive Product Care and Quality Team Lead. In this important role, you will lead our product care process, helping to manage and improve the performance of our on-market molecular diagnostic products. This includes coordinating investigations into product issues, finding root causes, and working with teams across the business to resolve problems quickly and effectively.

In this role you will be responsible for:

• Leading and improving the product care process, and ensuring company-wide understanding and use
• Reviewing complaints and technical support data to identify product issues
• Running investigations and root cause analysis to find the cause of product problems
• Coordinating lab testing and working out if issues are due to defects, user error, or processes
• Preparing clear reports and recommending corrective actions
• Working with cross-functional teams to fix product issues and track resolution
• Monitoring complaint trends and reporting on product performance
• Helping improve training materials, product documentation, and procedures
• Feeding lessons learned back into design, risk management and post-market surveillance
• Contributing to quality system activities, audits, and workplace safety initiatives
• Providing support to the CEO, CTO, and other departments as needed

To be successful as our PCQT Lead, you will possess:

• Demonstrated experience in Molecular Diagnostics, with knowledge of regulations, processes, products and technologies, 5 years +
• Demonstrated experience in Molecular Diagnostics across R&D, manufacturing, or post-market support
• Strong knowledge of IVD regulations and technologies such as PCR, methylation, or molecular biology
• Experience in managing product investigations and resolving issues in a regulated environment
• A solid understanding of ISO 13485 and related quality standards
• Great communication and teamwork skills, able to work across teams
• Strong project and stakeholder management skills
• Ability to lead and support cross-functional teams through a matrix structure

You will also have a Bachelor’s degree in a relevant science field such as Molecular Biology, Biotechnology, or Biomedical Science. You are familiar with CAPA, post-market surveillance, and complaint handling systems. Experience with Microsoft Office and quality documentation systems is essential. It is advantageous if you have experience in R&D, manufacture, and supply of research and IVD products.

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