Quality Engineer – MedTech AI, QMS & Compliance

PPD Search; Sydney; On-site; AUD 120,000 - 150,000; Full time

Benefits offered by this job

Flexible workplace

Learning environment

Growth opportunities

Hands-on experience

Job summary

PPD Search in Sydney is seeking a Quality Engineer to shape quality into products, processes, and culture. You will help design, implement and continuously improve the Quality Management System to stay scalable and compliant with global requirements.

The role requires close collaboration across Engineering, Manufacturing and Product teams. You will lead QA activities, audits, CAPAs, and supplier quality management to ensure safe and effective medical devices.

Qualifications

• ISO13485 / FDA / MDSAP knowledge and experience.
• QMS design, implementation, and audit readiness.
• Risk management per ISO14971.

Responsibilities

• Design, implement, and continuously improve the Quality Management System to be scalable and compliant.
• Partner with Engineering, Clinical, Manufacturing and Product teams on quality activities.
• Lead or support quality planning, audits, CAPAs, and regulatory submissions.
• Manage suppliers, supplier approvals, and quality agreements.

Skills

Quality Assurance

Regulatory Knowledge

Risk Management

QA Audits

Cross-functional Collaboration

Machine Learning Knowledge

Education

Engineering degree

Job description

PPD Search in Sydney is seeking a Quality Engineer to shape quality into products, processes, and culture. You will help design, implement and continuously improve the Quality Management System to stay scalable and compliant with global requirements.

The role requires close collaboration across Engineering, Manufacturing and Product teams. You will lead QA activities, audits, CAPAs, and supplier quality management to ensure safe and effective medical devices.