Quality Assurance Manager

Company Overview

Atmo Biosciences is a digital health business developing advanced gut-health diagnostics using an ingestible capsule that senses gas. Its work blends medical science, engineering, and data analytics to generate real-time visibility into gastrointestinal function. The company is focused on changing how gut disorders are monitored and treated, with the goal of supporting better clinical decisions and improved patient outcomes. The environment is fast-moving and innovation-led, with strong attention to quality, safety, and regulatory compliance.

Role Summary

This is a full-time, on-site Quality Assurance Manager position based in Melbourne, Victoria. The role centers on building, maintaining, and continuously improving the quality management system so it aligns with medical device and digital health requirements. The position covers policy and procedure development, document control, internal audits, non-conformance handling, CAPA management, and risk assessment activities. You will work closely with R&D, manufacturing, clinical, and regulatory teams to support product quality, compliance, and readiness for clinical and market use.

Key Responsibilities

The role includes coaching team members on quality expectations, tracking quality performance indicators, and leading improvement efforts that strengthen product reliability and patient safety.

Qualifications and Experience

Successful candidates should bring hands-on experience managing quality systems in medical devices, digital health, or another closely regulated industry. A strong working knowledge of standards and frameworks such as ISO 13485, ISO 14971, GMP, and relevant regional regulations is important. The role also requires comfort with documentation control, root cause analysis, risk management, and CAPA workflows, along with experience planning and conducting internal and external audits and engaging with regulatory or notified bodies. Strong analytical, problem-solving, and organizational abilities are needed to balance multiple priorities. Clear communication is essential, especially for training and influencing cross-functional teams. Collaboration across engineering, clinical, regulatory, and operations functions is a key part of the job.

Education

A bachelor’s degree in engineering, life sciences, quality management, or a similar field is preferred, or equivalent practical experience. Additional qualifications or certifications in quality are considered an advantage.

Preferred Background

Experience in startup or scale-up settings, along with familiarity with digital health technologies, will be especially valuable.