About the role
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
Lever builds modern recruiting software for teams to source, interview, and hire top talent. Our team strives to set a new bar for enterprise software with modern, well-designed, real-time apps. We participated in Y Combinator in summer 2012, and since then have raised $73 million. As the applicant tracking system of choice for Netflix, Eventbrite, ClearSlide, change.org, and thousands more leading companies, Lever means you hire the best by hiring together.
Lever is an equal opportunity employer. We are committed to providing reasonable accommodations and will work with you to meet your needs. If you are a person with a disability and require assistance during the application process, please don’t hesitate to reach out! We celebrate our inclusive work environment and welcome members of all backgrounds and perspectives. Learn more about our team culture and commitment to diversity and inclusion.