Quality Engineer - MedTech

About the role

A med-tech start-up based in Australia, founded 9 years ago and focused on improving women's health through AI-enabled technology, is hiring a Quality Engineer in Sydney. The role helps design, implement and continuously improve the Quality Management System so that it stays scalable, compliant and aligned with business needs. It is highly collaborative, working across Engineering, Clinical, Manufacturing and Product, and covers certification, regulatory submissions, design, manufacturing and post-market activities.

Key responsibilities

• Support quality planning, lead workstreams and maintain site certification by reviewing standards, regulations and guidance.
• Draft, review and implement QMS procedures and work instructions, and represent Quality Assurance on design projects and design changes.
• Implement and maintain Quality Plans and compliance reviews, and approve key documents and plans.
• Act as QA/QC representative for manufacturing, including process and software validation, and run internal and supplier audits and support external audits.
• Manage suppliers, the approved supplier list and quality agreements, and assess supplier performance.
• Handle nonconformances, complaints and CAPAs, and carry out investigations and root cause analysis.
• Develop corrective and preventative actions, and lead or support training, document and record control.

Required profile

• Engineering university qualification.
• Demonstrated experience in medical devices applying ISO 13485, 21 CFR Part 820 and MDSAP, with strong knowledge of FDA and TGA requirements.
• Broad experience across QMS covering design, manufacturing and post-market activities, and prior experience implementing a QMS.
• Experience with medical devices combining software, electronics and mechanical components.
• Full Australian working rights and work experience in Australia.
• Strong English, written and verbal, and strong problem-solving skills.

Required skills

• ISO 13485, 21 CFR Part 820, MDSAP, FDA and TGA regulatory requirements.
• ISO 14971 risk management and quality audit training and experience.
• Authoring QMS and audit-ready documents for design files, quality records and regulatory submissions.
• Solid understanding of machine learning principles.

The employer describes itself as a flexible, outcome-focused workplace with opportunities for learning and growth. Applications should quote reference number 3893.