Who We AreABOUT ENOVISTM Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows.
Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond.
For more information about Enovis, please visit You'll DoAt EnovisTM we pay attention to the details.
We embrace collaboration with our partners and patients and take pride in the pursuit of scientific excellence - with the goal of transforming medical technology as we know it.
Because that's how we change the lives of patients for the better.
And that's how we create better together.
Why work at Enovis?
See for yourself.
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.Quality Assurance EngineerLocation: Brisbane, AustraliaJob Title/High Level Position Summary: 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 robust 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.Key ResponsibilitiesServe as QA representative on new product development and sustaining engineering projectsParticipate in design and manufacturing reviews to ensure compliance with quality system requirementsDevelop and maintain DFMEA/UFMEA documentation and lead risk management discussions (ISO ***** aligned)Review and approve design control documentation including specifications, verification/validation records, and design outputsAct as subject matter expert for design quality during internal and external audits (ISO, FDA, GMP)Author, review, and maintain quality system procedures, work instructions,



and controlled documentationConduct internal audits across quality system processes and supporting business functionsEvaluate nonconforming material and support disposition decisions in collaboration with engineering and manufacturing teamsInvestigate trends in product failures, complaints, and nonconforming material to identify systemic issuesLead and manage Corrective and Preventive Actions (CAPA), ensuring effective root cause analysis and implementation of solutionsEnsure compliance with ISO, FDA, GMP, and other applicable regulatory requirementsSupport complex quality initiatives and cross-functional improvement projects as assignedScope / Role DimensionsSupports both new product development and sustaining engineering programsActs as QA subject matter expert across cross-functional teamsEnsures compliance with internal quality systems and external regulatory standardsParticipates in audit preparation, execution, and remediation activitiesInfluences design, manufacturing, and engineering decisions from a quality perspectiveMinimum QualificationsBachelor's degree in Biomedical Engineering, Mechanical Engineering, or related field required2+ years of experience in Quality Assurance or related function in a regulated industryExperience in medical device, aerospace, automotive, or other highly regulated industries requiredWorking knowledge of ISO ***** and quality system regulationsStrong technical writing skills and experience with controlled documentationExperience with manufacturing processes including metrology, machining, grinding, cleaning, and sterilizationProficiency in Microsoft Office Suite, especially Excel and WordStrong analytical and problem-solving skillsDesired QualificationsCQE, Lean, or Six Sigma certification preferredExperience with ISO ***** risk management standardsFamiliarity with tools such as SolidWorks, ePDM, Oracle R12, or Agile PLMExperience supporting FDA and international regulatory auditsStrong understanding of design controls and product lifecycle processesMultilingual ability (Spanish, German, or French a plus)Core CompetenciesQuality Leadership: Drives adherence to quality systems and regulatory standardsRisk Management: Applies structured approaches to identify and mitigate product risksTechnical Expertise: Strong understanding of engineering and manufacturing processesAudit Readiness: Ensures compliance and preparedness for internal and external auditsProblem Solving:



Investigates complex issues and drives effective CAPA resolutionCollaboration: Works effectively across engineering, manufacturing, and regulatory teamsAttention to Detail: Ensures accuracy in documentation, analysis, and decision-makingWorking ConditionsOffice-based environment with clean, organized, and well-lit workspaceLow to moderate noise levelsPrimarily computer-based work with cross-functional team interactionOccasional standing or extended desk work as requiredPhysical RequirementsAbility to sit or stand for extended periodsRegular use of computer and office equipmentWho We're Looking For:Quality Leader - passionate about ensuring safe and compliant medical devicesDetail-Oriented Professional - committed to precision in documentation and analysisCollaborative Influencer - able to guide cross-functional teams toward quality outcomesAnalytical Thinker - skilled in identifying trends and solving complex problemsAudit-Ready Mindset - comfortable operating in highly regulated environmentsContinuous Improver - focused on strengthening systems, processes, and outcomes"Creating better together".
It's the Enovis purpose, and it's what drives us and empowers us every day on a global scale.
We know that the power to create better - for our customers, our team members, and our shareholders - begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.
What does creating better together mean to us at Enovis?
Discover the "why" behind our purpose, values and behaviors: Our Enovis Purpose, Values and Behaviors on Vimeo Join us in creating better together.EQUAL EMPLOYMENT OPPORTUNITYEnovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law.
We also strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law.
We value the unique contributions that every employee brings to their role with Enovis.ABOUT ENOVISTMEnovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows.
Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond.
For more information about Enovis, please visit .
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📌 Quality Assurance Engineer (Brisbane)
🏢 Enovis
📍 Brisbane