Quality Assurance Engineer

Vista, CA

Full-time

Onsite

Entry, Mid Level

Enovis is a medical technology company that develops orthopedic medical devices. They are seeking a motivated Quality Engineer to support manufacturing and quality operations, focusing on maintaining product quality, ensuring regulatory compliance, and driving continuous improvement efforts.

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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

Qualification

Required

Bachelor’s degree in engineering or related fields
2+ years of quality experience in a regulated industry
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
Must be authorized to work in the U.S.

Preferred

Bilingual (Spanish/English) preferred
Mechanical, Biomedical, Industrial preferred
medical device preferred

Benefits

Enovis is a medical technology company that develops orthopedic medical devices.

Glassdoor

Founded in 1995

Wilmington, Delaware, USA

5001-10000 employees

https://enovis.com