Lead Analyst, R&D Technical Writing
Company: The Judge Group
Location: Fremont
Posted on: May 6, 2024
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Job Description:
Our client is currently seeking a Lead Analyst, R&D
Technical Writing or a 12 month + contract.Hybrid (first month
onsite 5 days a week then will be 3 days onsite 2 days at home)
Description/Comment: As part of Sustaining R&D, the Lead
Analyst, R&D Technical Writing is responsible for creating
end-user regulatory complaint product labeling. The specialist
contributes to new product development and design change
(sustaining) activities in the areas of labeling design/release,
technical writing, translation management, development of
artwork/images and development or improvement of processes for
improved efficiency and compliance. This role will engage with
cross functional teams to resolve obstacles effectively, be
responsible for meeting key labeling objectives, and
lead/collaborate on continuous improvement initiatives or special
activities having business impact.General Requirements: --- 4-6
years of relevant experience in developing or delivery of technical
publications that are part of products including writing, graphic
design, development of artwork/images, document control, related to
engineering, with part of experience in a medical device/regulated
industry--- Bachelor's Degree in Graphics or Language or equivalent
experience (Advanced degree may be considered towards years of
experience) --- Required to have a high level of service and
responsibility in managing highly detailed and varied workload from
internal customers and be comfortable working to tight timelines
--- Provide weekly summary of activities, create project plans,
prioritize, and effectively communicate updates to customers ---
Follow Good Document practices (GDP) for all documentation
created/reviewed and staying current on all required training for
incumbent position --- Subject Matter Expert (SME) in Microsoft
Applications (Word, Excel, PowerPoint, and Visio), Adobe Suite
(InDesign, FrameMaker, Photoshop, and Illustrator) --- Demonstrated
experience in the following: Instructions for Use, Training Guides,
Support of Electronic IFU (eIFU) and website, Translation
managementRequired Software: --- Microsoft applications (Word,
Excel, PowerPoint, and Visio) --- Adobe Suite (InDesign, Frame
Maker, Photo Shop, and Illustrator) --- Experience in website
design and testingNice to have Software: --- For Label Designer
Role: Database driven labeling system such as Prisym ID, Label
View, Loftware, Bartender Nice Label, and Easy Label, Computer
Aided Drafting (CAD) - Solidworks, AutoCAD StartEssential Duties &
Responsibilities (detailed description): --- Strong attention to
detail, reviews and audits other technical publications
deliverables and consistently delivers quality documentation with
no escapes --- Leads structured problem-solving initiatives to
resolve complex technical issues and document within appropriate
quality system documentation --- Drives creation of training and
communication materials that can be used by self or other staff to
convey new or updated processes. --- As regulations change and
quality systems are merged/aligned, execute the creation/refinement
of department and quality system SOPs, Work Instructions, forms,
and templates that have considerable graphical content with minimal
supervision --- Researches and builds knowledge about products,
service, technology, test method and documents in the clearest,
most logical way for greatest reader comprehension --- Fully
support the Quality Policy by building quality into all aspects by
maintaining compliance to all quality requirements and supporting
improvements that make it easier for the organization to maintain
compliance in complex areas --- Prepare for internal and external
audits by gathering records, supporting backroom, and providing
explanation for design areas developed by self with auditor in the
Front Room --- Lead recertification and other compliance projects
by managing key activities with stakeholders to execute required
changes and sometimes determine alternate design directions ---
Demonstrated extensive application of knowledge through delivery of
high-quality deliverables (SOPs, technical literature and Work
Instructions, engineering work product) to ensure continuity of
content style that meets applicable standards and is appropriate
for its intended audience --- Provides input to creation of
training and communication materials that can be used by self or
other staff to convey new or updated processes --- Experienced in
modifying existing and creating new Quality System documentation
(work instructions, standing operating procedures, forms,
checklists, and templates) --- Drives continuous improvement (NCs
and CAPAs) and assessment of current procedures, generation of
quality plans and identification of best practices --- Advocates
for creation or change in procedures and with complementary
procedures owned by others, along with appropriate technical
rationale to support recommended changes. --- Contributes to
process improvements to and drives key areas of strategic programs
that implement improved processes to reduce error rates.
Keywords: The Judge Group, Rancho Cordova , Lead Analyst, R&D Technical Writing, IT / Software / Systems , Fremont, California
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