Title: UDI project manager

Location: Irvine, CA

Duration: 6+ Months Contract



Need USC/GC/GC-EAD/H1B Only



*Job Description:*

SPOC for UDI project management activities

•             Coordinate between Client stakeholders and SMEs

•             Support the running of pilot initiatives.

•             Support in documentation, reports creation and understanding
of potential quality, design documentation challenges

•             Support the 2D barcode and direct part marking activities.

•             Review and/or develop project  schedules and plans for use by
internal and external stakeholders

•             Support with visualization technology, fingerprinting
technology and/or scanning technologies

•             Monitor and review any status reports needed to track
progress of project activity daily

•             Prepare project status reports for management team and others

•             Ensure project compliance with applicable regulations

•             Perform gap analysis, confer with system engineers, clients
and other personnel to implement Operating procedures, identify process
gaps using Fishbone diagram, provide technical information and create/track
project schedules using MS Project, SharePoint, JIRA and Agile
Scrum/Waterfall methodologies.

•             Working closely with the Technical Clients and propagate
change analysis results with cross-functional team and carry out
discussions on the requirements and coordinate training people on design
changes and support timelines.

•             Coordinate with development and testing and support inventory
remediation models for alternate designs and processing methods to assess
feasibility, operating condition effects, possible new applications and
necessity of modifications. Support suppliers and buyers on qualification
of UDI processes.

•             Support Research and analysis on tool enhancements impacting
Customer logistic services, Validate Customer design proposals,
specifications, manuals, and other data to evaluate the feasibility, cost,
and maintenance requirements of designs or applications.

•             Review, develop and edit SOPs to ensure they are consistent
with corporate objectives and regulatory agency compliance requirements and
support team to ensure project compliance with applicable medical
regulations i.e. state, federal, and international laws.

•             Research and design support to evaluate systems and processes
to meet requirements by applying knowledge of engineering principles.

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