This position is responsible for the design, implementation, and maintenance of quality assurance procedures to ensure external safety and compliance
Job Summary
This position is responsible for the design, implementation, and maintenance of quality assurance procedures to ensure external safety and compliance.
The role serves as the QA representative on the Material Review Board and leads root cause analysis for device failures.
Enovis is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate better patient outcomes.
Matching Summary
This position is responsible for the design, implementation, and maintenance of quality assurance procedures to ensure external safety and compliance.
Skills & Requirements
Must-have
Bachelor's in Science or Engineering
3+ years experience in regulated industry
Knowledge of ISO 13485 quality standards
Experience with GMP, FDA, and CMDR regulations
Root cause analysis and CAPA investigations
Process and equipment validation expertise
Nice-to-have
Solidworks and Agile PLM software knowledge
Lean or Six Sigma certification preferred
CQE certification preferred
Oracle R12 familiarity
Excellent customer service skills
Professional ethics and demeanor
Key Requirements
Bachelor's degree in Science or Engineering required
3+ years experience in Medical Device or highly regulated industry
Full-time work authorization in the United States required
No visa sponsorship available (H-1B not offered)
Ability to lift 50 lbs and perform physical tasks
Work Rights
Must have full-time work authorization in the US without sponsorship