Senior Quality Assurance Manager

We are 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 also oversees 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 providing quality strategic 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.
• Liaising with Production and QC to support compliance in manufacturing, quality control, and documentation practices.
• Managing and improving the electronic Quality Management System (eQMS), ensuring records are maintained and accessible.
• Leading internal and external audits, including planning, hosting, and ensuring timely closure of audit findings.
• Coordinating supplier audits and monitoring supplier quality performance in collaboration with Procurement.
• Overseeing nonconformance and CAPA processes to ensure timely resolution and drive continual improvement.
• Monitoring and reporting on QMS performance metrics, providing actionable insights for process enhancement.
• Analyzing quality data, including complaints and audit trends, to identify areas for improvement.
• Supporting post-market surveillance activities and ensuring findings are fed back into the QMS.
• Ensuring integration of risk management activities in line with ISO 14971 throughout product and process lifecycles.
• Contributing to setting and reviewing quality objectives and participating in annual management reviews.
• Coordinating 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 value diversity of thought and encourage anyone possessing the talent and drive to better healthcare 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 look forward to hearing from you

Please apply with a cover letter and CV below or via Seek. Enquiries can be made via email at careers@geneticsignatures.com. All applications will be treated in strict confidence. Due to high application volume, only shortlisted candidates will be contacted for an initial interview.

Genetic Signatures Ltd is an equal opportunity employer, fostering diversity and inclusion in the workplace. All qualified applicants will receive consideration without regard to race, color, religion, national origin, gender, age, sexual orientation, gender identity, disability, veteran status, or other protected classes.