Quality Assurance Engineer

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.