The Tools Administrator will assist in the ongoing adaptation and deployment of new tools such as JAMA. The administrator will work closely with functional leaders, organizational units, and subject matter experts to identify develop and deploy new business processes.
This role is part administrator, part quality analyst and part trainer. The Administrator will be responsible for executing on the day-to-day configuration, support, maintenance and improvement of the tools, qualification of the tools and associated processes.
The Administrator will manage the relationship with the software vendors and be responsible for documenting and updating internal processes and procedures, in relation to these software tools, for the quality system.
We would love to have you on the team if you are a self-starter with a strong project organization skill set, have a firm grasp of the design control process common in regulated industries, and are motivated to work in a highly technical, fast-paced, and cross-functional environment.
What you will do:
Work independently with members of the business to define and document the scope of new development requirements in an Agile environment.
A demonstrated ability to understand and articulate complex requirements
Ability to critically evaluate information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, abstract up from low-level information to a general understanding, and distinguish user requests from the underlying true needs
Ability to assess the impact of new requirements on all upstream and downstream applications, systems and processes
Work with our management team to establish suitable processes to support administrative, development, and change management activities
Document standards, guidelines, templates, and best practice procedures for both administrators and users of the system.
Administrative owner of the tools such as Jama software requirements management tool
Perform and own tasks including, but not limited to:
User account maintenance
Create filters and custom reports or dashboards for each project, as needed.
Customize workflows for multiple projects and maintain configuration of the tools.
Manage release cycles and validate the software tools.
Upgrade, backup, and baseline the project folders within each software tool.
Work closely with Quality engineering team for compliance.
Demonstrated ability to meet deadlines, handle and prioritize simultaneous requests, and manage laterally and upwards
Creative and analytical thinker with strong problem-solving skills
Must demonstrate exceptional verbal and written communication skills
Must demonstrate ability to communicate effectively at all levels of the organization
Previous experience working in a SCRUM or Agile environment preferred
Previous software development experience is preferred
What you need:
Minimum Qualifications (Required):
Bachelor’s degree in Computer Science, Computer Engineering or related field is preferred and minimum of 4+ years of experience as a Tools administrator or relevant experience is required.
Preferred Qualifications (Strongly desired):
Proven ability to design and implement new processes and facilitate user adoption.
Knowledge of Jama workflows, and permission schemes is preferred.
Understanding of engineering lifecycle phases and design control processes is preferred.
Experience validating third party tools to comply with Quality Management system and to follow FDA guidance is preferred.
Knowledge of System Modeling, Requirement Management and Test Management best practices when working with multiple concurrent programs is preferred.
Experience with software and hardware defect tracking processes is preferred.
Ability to communicate and work with external software vendors is preferred.
Ability to work independently and manage priorities on multiple tasks is required.
Excellent verbal and written communication skills is required.
Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820 is preferred.
