Medical Device Quality Assurance Specialist

3 weeks ago


Elkton, Maryland, United States Terumo Medical Corporation Full time

Terumo Medical Corporation is a leading medical device manufacturer with a strong commitment to quality and innovation. We are seeking a highly skilled Quality Engineer to join our team and contribute to the development and implementation of our Manufacturing Execution System (MES).

The MES Quality Engineer will work closely with cross-functional teams to ensure that projects related to MES are implemented compliantly and in a timely manner. This role will support production to drive continuous improvement and ensure compliance to Terumo's quality policy.

The ideal candidate will have a strong understanding of engineering principles and experience in a medical device or highly regulated industry. They will be responsible for developing and revising MES requirements documentation, procedures, control plans, PFMEAs, and training materials. Additionally, they will identify requirements gaps, investigate, and implement best-in-class Quality Engineering practices and solutions.

The MES Quality Engineer will also develop MES validation test cases and support Software Verification & Validation activities. They will work closely with the IT, Operations, Validation, and Engineering teams to ensure seamless integration and implementation of MES projects.

We are an equal opportunity employer and value diversity of background and opinion. We 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.



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