Quality Assurance Engineer

Job Description:

Job Description

At Enovis we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind 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.

As a key member of the Quality team, 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 - 2

Reports To: Manager, Quality Assurance

Location: Vista, CA | On-site

Work Authorization: Must be authorized to work in the U.S.

Position Summary:

We are looking for a motivated Quality Engineer to support manufacturing and quality operations in our medical device production environment. This role focuses on maintaining product quality, ensuring regulatory compliance, and driving continuous improvement efforts. The ideal candidate will have a strong foundation in quality systems and hands-on experience supporting production in a regulated industry.

Key Responsibilities:

• Support day-to-day quality activities on the manufacturing floor
• Investigate nonconformances and assist in root cause analysis and CAPA implementation
• Perform process monitoring, data analysis, and assist in statistical process control
• Participate in validation efforts (IQ, OQ, PQ) and process capability assessments
• Ensure documentation compliance with internal procedures and regulatory standards
• Collaborating with cross-functional teams on new product introductions, product changes, and process improvements
• Assist in internal audits and regulatory inspection readiness
• Author and revise quality records, inspection plans, and work instructions
• Support training and quality awareness initiatives across teams

Qualifications:

• Bachelor's degree in engineering or related fields (Mechanical, Biomedical, Industrial preferred)
• 2+ years of quality experience in a regulated industry (medical device preferred)
• Familiarity with FDA QSR, ISO 13485, and other relevant regulatory standards
• Working knowledge of root cause analysis, risk management, and CAPA processes
• Experience with quality tools such as Minitab, SPC, and basic validation principles
• Bilingual (Spanish/English) preferred

"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.

Watch this short video and discover what creating better together means to us at Enovis:

Our Enovis Purpose, Values and Behaviors on Vimeo

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. Visit www.enovis.com to learn more.

EQUAL EMPLOYMENT OPPORTUNITY:

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and 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 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.

EOE AA M/F/VET/Disability Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.