Associate Quality Engineer

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

Assists in the planning, execution, and implementation of activities to support receiving inspections, supplier management, and risk management. Supports product or system non-conformance investigation and escalations.

KEY DUTIES

• Design, evaluates, and implements fixtures / tools to support incoming inspections.
• Develops and validates methods to automate / optimize inspection methods.
• Creates test methods and test method validation protocols and reports.
• Ensures adequate execution of test method validations.
• Assists in the creation and completion of component FMEAs.
• Analyses and investigates non-conformities; triggers CAPA escalations as needed.
• Provides technical support to the Supplier Quality program.
• Monitors efficiency of RI processes and recommends improvements.

COMPANY

REQUIREMENTS

Must work within requirements of company handbook and policy statements.

Note: Company Handbook, Policy Statement and Authorization of Limits do not form part of the quality system

QUALITY

REQUIREMENTS

1. Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.
2. Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality.
3. Responsible to ensure facility, processes and documentation always remain in a state of audit readiness.

EH&S REQUIREMENTS

1. Take care of your own health and safety and that of others who may
2. be affected by your actions.
3. Work co-operatively to highlight issues affecting Environmental Health and Safety

QUALIFICATIONS & EXPERIENCE

Excellent written and verbal communication

• Ability to interact with all levels within the organization.
• Analytical skills for compiling and analyzing data (engineering statistics)
• Computer and software skills (SolidWorks strongly desired)
• Light Lifting
• 4 – year engineering/science degree. No previous experience needed
• Working knowledge of Lean Manufacturing and Six Sigma a plus
• Experience and understanding of quality system regulations (e.g. 21CFR820, ISO13485)
• Strong written, verbal, analytical and interpersonal skills
• Self-motivated
• Ability to multitask.