Quality Assurance Engineer at Enovis · Enovis…

Quality Assurance Engineer

Location: Enovis Australia- Fortitude Valley (Precision AI)

Who We Are

ABOUT ENOVIS™

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 www.enovis.com.

What You'll Do

At Enovis™ 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.

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 14971 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, GMP, 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 Biomedical 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 manufacturing processes including metrology, machining, grinding, cleaning, and sterilization
• 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 14971 risk management standards
• Familiarity with tools such as SolidWorks, ePDM, Oracle R12, or Agile PLM
• Experience supporting FDA and international regulatory audits
• Strong understanding of design controls and product lifecycle processes
• Multilingual ability (Spanish, German, or French a plus)

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
• 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

• Office-based environment with clean, organized, and well-lit workspace
• Low to moderate noise levels
• 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 safe 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.

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 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.