Quality Systems Engineer II — Impact & Compliance

Terumo Aortic; Town of Florida (NY); On-site; USD 90,000 - 120,000; Full time

Job summary

Terumo Aortic seeks a Quality Engineer II to support quality engineering operations for receiving, in-process, and finished product. The role emphasizes maintaining regulatory compliance, developing QC standards, and validating new products and production lines.

You will review nonconforming products, perform risk assessments, and drive supplier and production quality improvements while ensuring efficiency and compliance across manufacturing.

Qualifications

• Bachelor’s degree in a technical discipline and minimum five years of experience in medical device quality assurance.
• 1–3 years’ experience in Manufacturing Engineering or Quality Engineering with validation experience.
• Working knowledge of FDA 21 CFR 820 and ISO 13485/14971.
• Leadership ability and strong organizational skills; hands-on, high-energy teamwork.

Responsibilities

• Supports quality engineering operations across receiving inspection, in-process, and finished product.
• Reviews nonconforming products and conducts risk assessments and failure investigations.
• Drives supplier and production quality improvements while maintaining compliance.
• Interacts with cross-functional teams to resolve quality issues and support CAPAs.

Skills

Communication

Analytical skills

Six Sigma

ASQ Certification

Education

Bachelor’s degree in a technical discipline

Tools

SAP

Job description

Terumo Aortic seeks a Quality Engineer II to support quality engineering operations for receiving, in-process, and finished product. The role emphasizes maintaining regulatory compliance, developing QC standards, and validating new products and production lines.

You will review nonconforming products, perform risk assessments, and drive supplier and production quality improvements while ensuring efficiency and compliance across manufacturing.