Quality Assurance Engineer

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 Companys extensive range of products services and integrated technologies fuels active lifestyles in orthopedics and more information about Enovis please visit .

What Youll 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 thats how we change the lives of patients for the better. And thats 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

Bachelors 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 Were 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. Its the Enovis purpose and its 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.