Supplier Quality Engineer II

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

At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy.

The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.

Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associate’s role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide.

Position Summary

Responsible for supporting the quality engineering operations of receiving inspection, in-process and finished product and maintaining processes and methods in accordance with the company standards. Reporting on the performance of the assigned quality areas. Responsible to maintain regulatory compliance.Develops quality standards and controls. Develops product and process qualifications/validation protocols/reports for new products and existing manufacturing production lines. Advises company management on quality assurance requirements. Review non-conforming product along with product risk assessment and perform product failure investigations. Drives Supplier and Production Quality improvements, including efficiency and productivity improvements while maintaining compliance.

Minimum Skills & Capabilities:

• Works with all levels within the company.
• Ability to organize and conduct multiple, parallel tasks
• Understanding of quality system regulations (ISO13485, 21CFR820)
• Ability to interact with all levels within organization
• Analytical skills for compiling and analyzing data
• Mechanically inclined
• Knowledge of DOE, SPC, Gage R&R, and sampling plans
• Computer and software skills
• Ability to motivate others and improve efficiency
• ASQ Quality Engineer Certification a plus
• Statistics and data analysis

Minimum Knowledge & Experience required for the position:

• Bachelor’s degree in a technical discipline (Mechanical/Biomedical/Electrical engineering), or equivalent, with a minimum of five years of experience in medical device quality assurance.
• Minimum 5 years’ experience in Manufacturing Engineering or Quality Engineering with preference having validation experience
• Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) - ISO 13485 and ISO 14971).
• Understanding of required standards / regulations impacting Medical Devices.
• Leadership ability and organizational skills.
• Strong team oriented professional with good interpersonal skills who is hands‑on with a high energy approach to work.
• Must have experience handling nonconforming events