Quality Assurance Engineer
About The Position
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. 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.
Requirements
- 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
Nice To Haves
- Bilingual (Spanish/English) preferred
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
