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Quality Ops Engineering Tech

3 months 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

This position is responsible to support all activities related to Quality Operations. QE Technicians will support activities including, but not limited to: non-conforming product activities, investigation of failures, test method validations, procedure updates, training, and other departmental operating activities.

Job Details/Responsibilities

1. Perform activities associated with the non-confirming product process: identification, containment, segregation, and evaluation.
2. Perform failure investigations with limited scope and routine analysis.
3. Execute activities associated with inspection methods: calibration, training, TMV execution
4. Perform data collection and limited data analysis.
5. Execute procedure updates with guidance from supervisor.
6. Coordinate calibration activities as necessary.
7. Develop training material with guidance from supervisor and provide training to production personnel.
8. Coordinate and conduct rework and inspection and testing of finished goods as needed to verify that they meet specifications.
9. Assists with administrative functions and supports other department tasks as needed.
10. Participates in project performance team meetings on behalf of the job unit in order to provide ideas, methods or processes for unit/company performance improvement

Knowledge, Skills and Abilities (KSA)

    • General computer skills.
    • Effective verbal and written communication and organizational skills.
    • Quality mindset: process oriented, root cause oriented, customer oriented, sense of urgency, accountability, and responsibility.
    • Requires the ability to solve basic problems and recommend solutions.
    • Ability to use testing equipment (i.e. calipers, micrometers, microscope, optical comparator, Instron, Laser Mic, Lubricity Tester, etc.).
    • Mathematical knowledge and aptitude, including algebra and utilization of sampling plans/statistical charts.
    • Requires ability to notice trends and escalate situations/problems to supervisor.
    • 20/20, equivalent, or corrected vision.
Qualifications/ Background Experiences
    • Required: 1-3 prior technical engineering, quality assurance, or manufacturing support experience.
    • Required: 1-3 years of FDA-Regulated industry experience.
    • Requires a high school diploma. Post high school education beneficial but not required.

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.