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 Assurance 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

Reports To: Manager, Quality Assurance

Location: Vista, CA | On-site

Travel requirements: Up to 20% (domestic and international supplier sites)

Work Authorization: Must be authorized to work in the U.S. (No visa sponsorship available)

Role Summary:

We are seeking a dynamic Supplier Quality & Quality Systems Engineer to manage supplier quality programs and drive compliance and performance across our site's quality system. This role supports supplier qualification and performance, leads internal and external audits, facilitates regulatory body inspections, and ensures alignment with product safety and registration requirements. The ideal candidate will be experienced in both supplier quality and quality systems within the medical device industry.

Key Responsibilities:

• Lead supplier audits, assessments, and corrective action processes (SCARs)
• Manage supplier performance metrics, scorecards, and improvement plans
• Support product safety registration processes (e.g., CE, UL, FDA submissions), including coordination with Regulatory Affairs
• Own and drive the site's CAPA, NCMR, and training processes
• Support the development and validation of supplier-provided components and materials
• Drive root cause investigations for supplier-related nonconformances (NCMRs, SCARs)
• Collaborate with R
• Lead and support internal audits; coordinate and prepare for external and regulatory body inspections (FDA, ISO, MDSAP)

Qualifications:

• Bachelor's degree in engineering or related technical field (Mechanical, Biomedical, Industrial preferred)
• 5+ years of experience in supplier quality and/or quality systems within a regulated industry (medical devices preferred)
• Strong understanding of FDA QSR, ISO 13485, MDSAP, EU MDR, and applicable global regulations
• Experience supporting or leading regulatory inspections (FDA, Notified Bodies, etc.)
• Auditor certification (e.g., CQA, lead auditor ISO 13485) required or ability to obtain within 6 months
• Experience with product safety standards, registration, and compliance (CE marking, UL, etc.)
• Bilingual (Spanish/English) a plus

"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.