Strategic Supplier Quality Engineer - Medical Devices

Terumo Aortic; Florida; On-site; USD 85,000 - 120,000; Full time

Job summary

Terumo Aortic seeks a Quality Engineer to support receiving inspection, in‑process, and finished product quality assurance. You will maintain regulatory compliance, develop quality standards, and create validation protocols for new and existing manufacturing lines.

You will advise management on QA requirements, review nonconforming products, and drive supplier and production quality improvements while ensuring FDA/ISO compliance.

Qualifications

• Bachelor’s degree in a technical discipline with 5+ years of experience in medical device quality assurance.
• Experience with FDA 21 CFR 820 and ISO 13485/14971.
• Experience handling nonconforming events and root cause analysis.

Skills

Quality regulations

ISO13485

FDA 21 CFR 820

Multi-tasking

Cross-functional communication

Data analysis

Mechanical aptitude

DOE/ SPC / Gage R&R

Leadership

ASQ CQE certification

Statistics

Education

Bachelor’s degree in Mechanical/Biomedical/Electrical engineering

Job description

Terumo Aortic seeks a Quality Engineer to support receiving inspection, in‑process, and finished product quality assurance. You will maintain regulatory compliance, develop quality standards, and create validation protocols for new and existing manufacturing lines.

You will advise management on QA requirements, review nonconforming products, and drive supplier and production quality improvements while ensuring FDA/ISO compliance.