Quality Engineer – Medical Devices

About the role

The Quality Engineer will shape how quality is embedded in our products, processes and culture. You will design, implement and continuously improve a scalable Quality Management System that meets regulatory and business requirements.

Key responsibilities

• Design, author and maintain QMS procedures, work instructions and quality plans.
• Lead certification activities, regulatory submissions and support internal and external audits.
• Manage supplier approvals, quality agreements and performance assessments.
• Handle non‑conformances, complaints, CAPA and conduct root‑cause investigations.
• Represent QA/QC on design projects, manufacturing validation and post‑market activities.

Required profile

• Engineering degree with experience in medical devices.
• Hands‑on knowledge of ISO 13485, 21 CFR Part 820, MDSAP and global regulations (FDA, TGA).
• Proven experience across design, manufacturing and post‑market quality activities.
• Full Australian working rights and strong English communication skills.

Required skills

• ISO 13485 implementation
• 21 CFR Part 820 compliance
• MDSAP familiarity
• ISO 14971 risk management
• Quality audit planning and execution
• QMS documentation authoring
• Machine Learning principles awareness

What we offer

• Highly flexible work environment focused on outcomes.
• Supportive learning culture with growth opportunities for high performers.
• Hands‑on experience developing groundbreaking solutions for women’s health.