Senior Quality Engineer, Med-Tech AI Solutions

PPD Search; Sydney; Hybrid; AUD 100,000 - 140,000; Full time

Benefits offered by this job

Flexible workplace

Learning opportunities

Growth opportunities

Job summary

PPD Search is seeking a Quality Engineer to join a med-tech start-up focused on women’s health. You will shape the QMS, drive compliance with ISO13485, FDA TGA standards, and collaborate across Engineering, Clinical, Manufacturing and Product teams to deliver safe, effective devices.

You will lead audits, manage suppliers, handle CAPAs, and contribute to regulatory submissions while supporting training and document control for a scalable quality system.

Qualifications

• Engineering qualification with a strong quality focus and regulatory awareness.
• Experience applying ISO13485, 21 CFR Part 820 and MDSAP.
• Broad QMS experience across design, manufacturing and post-market activities.
• Experience with medical devices incorporating software, electronics and mechanical components.
• Strong risk management applying ISO14971; audit training and experience.
• Authoring QMS and audit-ready documents for design files and regulatory submissions.

Responsibilities

• Design, implement and improve the QMS to be scalable and compliant.
• Collaborate with Engineering, Clinical, Manufacturing and Product teams.
• Support certification activities and regulatory submissions.
• Draft, review and implement QMS procedures and work instructions.
• Act as QA/QC representative for manufacturing activities; conduct audits.
• Manage suppliers and quality agreements; review nonconformances and CAPAs.
• Lead investigations and root cause analysis; drive corrective actions.

Skills

Quality management

Regulatory knowledge

Quality audits

Risk management

Root cause analysis

ML concepts

Supplier management

Education

Engineering degree

Job description

PPD Search is seeking a Quality Engineer to join a med-tech start-up focused on women’s health. You will shape the QMS, drive compliance with ISO13485, FDA TGA standards, and collaborate across Engineering, Clinical, Manufacturing and Product teams to deliver safe, effective devices.

You will lead audits, manage suppliers, handle CAPAs, and contribute to regulatory submissions while supporting training and document control for a scalable quality system.