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Quality Engineer I

1 month ago

Elkton, United States Terumo Full time

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

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

The position as a Quality Engineer will work closely with the Operations and Engineering Teams to ensure that goods and current products are well designed and manufactured to meet or exceed the customer expectations and requirements. This position will support manufacturing production and is responsible for performing corrective actions and driving continuous improvement initiatives. Ensure compliance to Terumos quality policy, respond to customer complaints, perform audits, develop test methods, and/or write procedures for material characterization.

Job Details/Responsibilities

1. Responsibilities for developing and maintaining quality specifications for products, materials, equipment, facility, and process controls.
2. Investigation team member for internal and external quality issues, driving timely and effective corrective actions
3. Provide data analysis and implementation of corrective actions and continuous improvement activities
4. Identification and implementation of effective process control systems to support the on-going manufacturing of products to meet or exceed internal and external requirements
5. Responsible for quality metrics associated with Operations such as, product nonconformances and process monitoring (yield).
6. Creates, reviews, and approves documentation related to product quality, manufacturing process, and compliance.
7. Development of training materials and facilitation of training to production personnel.
8. Responsible for compliance to company’s quality systems.
9. Execute activities associated with inspection methods: calibration, training, and TMV execution.
10. Perform other job-related duties.

Job Responsibilities (continued)

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

    • Communication proficiency; verbal and written.
    • Problem Solving and Critical Thinking
    • Detail Oriented
    • Initiative
    • Decision Making
    • Results Driven
    • Good organizational and time management skills.
    • Excellent computer skills
    • Good writing, mathematics, and statistics skills.
Qualifications/ Background Experiences
    • Bachelors degree (4 years) or higher from an accredited course of study, in engineering, engineering technology, computer science, mathematics, or physics
    • Experience working in a manufacturing environment preferred
    • One year experience in a medical device quality assurance environment 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 testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.