Who We Are
ABOUT ENOVISTM
What You'll Do
At 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?
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.
Job Title:
Quality Assurance Engineer
Location:
Brisbane, Australia
Job 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 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.
Key Responsibilities
Serve as QA representative on new product development and sustaining engineering projects
Participate in design and manufacturing reviews to ensure compliance with quality system requirements
Develop 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 outputs
Act 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 documentation
Conduct internal audits across quality system processes and supporting business functions
Evaluate nonconforming material and support disposition decisions in collaboration with engineering and manufacturing teams




Investigate trends in product failures, complaints, and nonconforming material to identify systemic issues
Lead and manage Corrective and Preventive Actions (CAPA), ensuring effective root cause analysis and implementation of solutions
Ensure compliance with ISO, FDA and other applicable regulatory requirements
Support complex quality initiatives and cross-functional improvement projects as assigned
Scope / Role Dimensions
Supports both new product development and sustaining engineering programs
Acts as QA subject matter expert across cross-functional teams
Ensures compliance with internal quality systems and external regulatory standards
Participates in audit preparation, execution, and remediation activities
Influences design, manufacturing, and engineering decisions from a quality perspective
Minimum Qualifications
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 ***** and quality system regulations
Robust 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
Desired Qualifications
CQE, Lean, or Six Sigma certification preferred
Experience with ISO ***** risk management standards
Familiarity with tools such as SolidWorks, eQMS.
PowerBI, Oracle R12, or Agile PLM
Experience supporting FDA and international regulatory audits
Strong understanding of design controls and product/software lifecycle processes
Core Competencies
Quality Leadership: Drives adherence to quality systems and regulatory standards
Risk Management: Applies structured approaches to identify and mitigate product risks




Technical Expertise: Strong understanding of engineering and manufacturing processes and software as a medical device
Audit Readiness: Ensures compliance and preparedness for internal and external audits
Problem Solving: Investigates complex issues and drives effective CAPA resolution
Collaboration: Works effectively across engineering, manufacturing, and regulatory teams
Attention to Detail: Ensures accuracy in documentation, analysis, and decision-making
Working Conditions
Hybrid working - 2/3 days office based per week
Primarily computer-based work with cross-functional team interaction
Occasional standing or extended desk work as required
Physical Requirements
Ability to sit or stand for extended periods
Regular use of computer and office equipment
Who We're Looking For
Quality Leader – passionate about ensuring protected and compliant medical devices
Detail-Oriented Professional – committed to precision in documentation and analysis
Collaborative Influencer – able to guide cross-functional teams toward quality outcomes
Analytical Thinker – skilled in identifying trends and solving complex problems
Audit-Ready Mindset – comfortable operating in highly regulated environments
Continuous 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.
Join us in creating better together.
EQUAL EMPLOYMENT OPPORTUNITY
Enovis 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.
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📌 Quality Assurance Engineer (Brisbane)
🏢 Enovis
📍 Brisbane