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Terumo Medical Corporation is a market leader in minimally-invasive entry site management, lesion access and embolization solutions. This position will work cross-functionally and provide the engineering support and administration of TMC Quality Software Systems.
The Operations Software Systems Administrator will integrate and maintain the Manufacturing, Engineering and Quality Software Systems applications that enables TMC to maintain regulatory and compliance requirements in the design and manufacture of medical devices.
Job Details
Provide System Administration for current and new Manufacturing and Quality Software systems
Assist the Software Systems Engineers and Specialists to administer and support the Quality and Manufacturing Systems Software Applications throughout TMC.
Cross train on other business systems as needed.
Working knowledge of quality processes and controls
Assist end users with standard functionalities of the various applications
Provide software engineering administrative support
Assist the engineers and specialists with the execution of projects, installations, upgrades, and revisions from an administrative perspective
Support the applications/systems database activities and schedules
Assist with the requirements and testing documentation for new software solutions and changes to existing systems
Performs other job related duties as assigned
Qualifications Knowledge, Skills and Abilities (KSAs):
Must be proficient with MSWord, Excel and Power Point office applications
Must demonstrate and model effective listening, written and verbal communications, sound logical judgment, and organizational skills.
Excellent communication skills both verbal and written is required.
Knowledge of GAMP5 Methodology preferred but not required
Knowledge of FDA process validations, including development of protocols and execution of protocols is a plus.
Background Experiences
Associate’s Degree with technical training preferred or equivalent combination of education & experience.
Experience with configurable software applications such as Master Control, EtQ, Maximo and Documentation Control (TMS Web)
Knowledge of MES software solutions is a plus
Experience in an FDA regulated industry, medical device or pharmaceutical preferred
