Quality Assurance Engineer
Brisbane, Queensland, Australia Hybrid
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About the role
As a key member of the Quality Assurance, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. We are seeking a highly skilled QA Engineer to lead and support quality assurance activities across new product development and sustaining engineering programs. This role is responsible for ensuring compliance with internal quality systems, industry standards, and global regulatory requirements while serving as a key QA representative on cross-functional product development initiatives. The QA Engineer will play a critical role in design controls, risk management, audit readiness, and continuous improvement of the quality system. This position requires strong technical judgment, deep knowledge of regulated environments, and the ability to influence cross-functional teams to ensure product safety, quality, and compliance throughout the product lifecycle.
What you'll bring
- Bachelor’s degree in Engineering, Mechanical Engineering, or related field required
- 2+ years of experience in Quality Assurance or related function in a regulated industry
- Experience in medical device, aerospace, automotive, or other highly regulated industries required
- Working knowledge of ISO 13485 and quality system regulations
- Strong technical writing skills and experience with controlled documentation
- Experience with software as a medical device
- Proficiency in Microsoft Office Suite, especially Excel and Word
- Strong analytical and problem-solving skills
- CQE, Lean, or Six Sigma certification preferred
- Experience with ISO 14971 risk management standards
- Familiarity with tools such as SolidWorks, eQMS.
- PowerBI, Oracle R12, or Agile PLM