Quality Engineer

This Australian med-tech start-up, established 9 years ago, is working to improve women’s health, leveraging AI-enabled technology to reinvent care for women. They utilise cutting edge platforms and create completely novel technologies to generate solutions that seek to treat complications that have been previously undiagnosable.

THE COMPANY YOU WOULD BE JOINING This Australian med-tech start-up, established 9 years ago, is working to improve women’s health, leveraging AI-enabled technology to reinvent care for women. They utilise cutting edge platforms and create completely novel technologies to generate solutions that seek to treat complications that have been previously undiagnosable.

EMPLOYEE BENEFITS This organisation prides themselves on being an extremely flexible workplace, with a focus on outcomes, rather than location or hours. The company offers a uniquely supportive environment for learning, as well as opportunities for growth for high performers. You will have the opportunity to gain hands‑on experience and develop your knowledge, while creating groundbreaking solutions that truly make a difference to women’s health.

THE OPPORTUNITY – WHAT YOU WILL LEAD & GROW This Quality Engineer position will directly influence how quality is built into their products, processes, and culture. Joining at an exciting stage of growth, this role will help design, implement, and continuously improve the Quality Management System, ensuring it remains scalable, compliant, and aligned with the business needs. This is a highly collaborative role requiring close partnership across Engineering, Clinical, Manufacturing and Product. You will contribute across all aspects of the QMS, including certification activities and regulatory submissions along with design, manufacturing and post market activities. This role is critical to ensure we deliver safe, effective, and innovative products. The position will support quality planning, including leading some workstreams, to achieve and maintain site certification and review relevant standards, regulations and guidance and incorporate into the QMS as needed. The role will draft, review and implement new or updated QMS procedures and work instructions by working closely with cross functional team members and represent Quality Assurance on design projects including new products and design changes. You will implement and maintain Quality Plans and Compliance reviews and provide constructive review and approval on key documents and plans. You will act as QA/QC representative for manufacturing activities, including process and software validation and conduct internal and supplier audits and support external audits and ensure appropriate audit documentation and close out of deficiencies. You will manage suppliers, create and maintain the approved supplier list and quality agreements, and support ongoing performance assessments. You will manage, handle and review nonconformances, complaints, other product quality issues and CAPAs. You will perform investigations and root cause analysis, develop and implement corrective and preventative actions in collaboration with other departments and lead or support core Quality Assurance activities including training, document and record control.

WHAT YOU WILL NEED TO GET THE JOB Engineering university qualification. Demonstrated experience working in medical devices and applying the requirements of ISO13485, 21 CFR Part 820 and Medical Device Single Audit Program (MDSAP). Strong knowledge of global regulatory requirements, including FDA and TGA. Broad experience across Quality Management Systems including design, manufacturing and post market activities. Experience with medical devices incorporating software, electronics and mechanical components. Strong understanding and application of risk management according to ISO14971. Quality audit training and experience. Practical experience authoring QMS and audit-ready documents for design files, quality records and regulatory submissions. Strong English communication, written and verbal, with full Australian working rights and ability to collaborate effectively with cross functional teams, with work experience in Australia. Strong problem-solving skills and leading resolution of risks and implementation of product quality improvements. Solid understanding or experience with Machine Learning principles. Prior experience implementing a QMS.

#J-18808-Ljbffr