As a key member of the Quality Assurance team, you will help Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes
Job Summary
As a key member of the Quality Assurance team, you will help Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.
You will lead quality improvement projects, ensure patient safety through compliance, and support new product introductions from a quality standpoint.
The role involves collaboration with cross-functional teams and providing technical leadership and mentorship to the Quality Engineering team.
Matching Summary
As a key member of the Quality Assurance team, you will help Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.
Skills & Requirements
Must-have
Medical device quality assurance
FDA QSR and ISO 13485 compliance
Validation master plans and protocols
Lean Six Sigma methodologies
Risk management and quality assurance
Cross-functional team collaboration
Quality system document management
Nice-to-have
Mentorship and technical leadership
Orthopedic implants quality experience
Statistical process control expertise
Supplier quality assurance
Experience with electronic QMS software
Project management skills
Continuous improvement culture
Key Requirements
Bachelor’s degree in engineering or related field
10+ years experience in Quality Engineering or Assurance
In-depth knowledge of ISO 13485 and FDA QSR (21 CFR Part 820)
Experience in validation engineering for medical devices
Strong understanding of ISO 14971 risk management
Preferred: Master’s degree or advanced credentials
Preferred: ASQ Certified Quality Engineer or Six Sigma Black Belt