Quality Engineer - MedTech AI, Build Scalable QMS

PPD Search; Sydney; On-site; AUD 90,000 - 130,000; Full time

Job summary

PPD Search is hiring a Quality Engineer to shape the Quality Management System, ensuring scalable, compliant processes across design, manufacturing and post-market activities. You will partner with Engineering, Clinical, Manufacturing and Product teams to deliver safe, effective and innovative medical devices.

In this role you will lead quality planning, audits, CAPAs and supplier quality management, while maintaining robust documentation and regulatory submissions.

Qualifications

• Engineering degree with medical devices experience.
• Knowledge of ISO13485, 21 CFR Part 820 and MDSAP with global regulatory requirements (FDA/TGA).
• Broad experience across QMS including design, manufacturing and post-market activities.
• Experience with devices combining software, electronics and mechanics.
• Strong ISO14971 risk management understanding; audit training preferred.
• Experience authoring QMS and audit-ready documents for design files and regulatory submissions.
• Strong English communication; Australian working rights and cross-functional collaboration.
• Problem-solving skills and leading risk resolution with product quality improvements.
• Solid understanding of Machine Learning principles.
• Experience implementing a QMS.

Responsibilities

• Lead the design, implementation, and continuous improvement of the Quality Management System.
• Collaborate across Engineering, Clinical, Manufacturing and Product teams to ensure product quality.
• Support certification activities, regulatory submissions and internal/external audits.
• Draft, review, and implement QMS procedures and work instructions.
• Manage supplier quality, CAPAs, nonconformances, complaints and audits.
• Conduct investigations and root cause analysis to drive corrective actions.

Skills

English communication

Problem-solving

Cross-functional collaboration

Quality mindset

Root cause analysis

Education

Engineering degree

Job description

PPD Search is hiring a Quality Engineer to shape the Quality Management System, ensuring scalable, compliant processes across design, manufacturing and post-market activities. You will partner with Engineering, Clinical, Manufacturing and Product teams to deliver safe, effective and innovative medical devices.

In this role you will lead quality planning, audits, CAPAs and supplier quality management, while maintaining robust documentation and regulatory submissions.