Supplier Quality Engineer II - TA

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.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

Join us and help shape wherever we go next!

Advancing healthcare with heart

Job Summary Provides technical support to improve the quality, efficiency, output, and safety of existing components and manufacturing processes. Supports critical component and supplier changes, component qualification, inspection methods, tooling, risk analysis, validation, and Quality System activities for aortic stent grafts and delivery systems.

Job Details/Responsibilities Work with key suppliers to identify and develop component improvements that meet quality, cost, and business requirements and support critical component and supplier changes.

Support component qualification activities and improvements and help bring new or existing components through applicable design and qualification phases.

Develop fixtures, jigs, gages, prototypes, tooling, and equipment that support component inspection, manufacturing, testing, and process improvement activities.

Document inspection and manufacturing methods and support test-method validation, software validation, and other required validation activities.

Support the design, evaluation, implementation, monitoring, and operation of systems and processes used to manufacture aortic stent grafts and delivery systems.

Help develop and implement manufacturing processes and execute process-validation activities, including IQ, OQ, and PQ protocols and reports.

Conduct risk and statistical analyses, including DFMEA and PFMEA, maintain required documentation, monitor process performance through observations and data, and support CAPAs, NCRs, CQPs, TMVs, and other Quality System activities.

Knowledge,

Skills and Abilities

(KSA)
Knowledge of engineering statistics and the ability to perform statistical analyses on data groups.

Knowledge of AutoCAD and Solid Works.

Strong technical-writing skills for manufacturing instructions, test methods, protocols, reports, and related controlled documentation.

Ability to organize and conduct experiments independently and analyze and solve technical problems.

Hands-on ability to engineer and build prototypes, tooling, fixtures, processes, and equipment.

Knowledge of component qualification, inspection methods, test-method validation, software validation, process validation, and risk-analysis methods, including DFMEA and PFMEA.Excellent written and verbal communication skills and the ability to work effectively under pressure.

Qualifications/ Background Experiences Technical degree or certificate, or equivalent education and experience.

Experience in a technical, engineering, manufacturing, component, tooling, inspection, or validation environment.

Medical-device industry experience is preferred.

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic…