Technical Writer
Listed on 2026-01-12
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Quality Assurance - QA/QC
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Healthcare
Technical Writer / Labelling Analyst
Location: Fremont, CA
Duration: 12 months
Pay range: $41.93 - $43.33
Posted: 07 January 2026
Reference: 987509
Analyst, R&D Technical Writing, as a part of Packaging R&D, is responsible for creating end‑user regulatory‑compliant product labeling that will support business requirements. The specialist may contribute to new product development and design change (sustaining) activities in the areas of label design/release, development of artwork/images, and improvement of processes for enhanced efficiency and compliance. This role will engage with and mobilize cross‑functional teams to resolve obstacles effectively, meet key labeling objectives, and lead or collaborate on continuous improvement initiatives or special activities with business impact.
GeneralRequirements
- 2-4 years of relevant experience
- Bachelor's degree in graphics, language or an equivalent field (advanced degree may be considered toward years of experience)
- High level of service and responsibility managing a varied workload from internal customers while working within 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 stay current on required training for the position
- Proficiency with Microsoft applications (Word, Excel, PowerPoint, and Visio)
- Proficiency with Adobe Suite (InDesign, Photoshop, and Illustrator)
- Experience with database‑driven labeling systems such as Prisym , Label View, Loftware, Bartender, Nice Label, and/or Easy Label
- Support IFU development and release in PLM for new product development and design changes, ensuring congruency with product labeling and strong attention to detail
- Manage tasks related to IFU/Literature printing suppliers and translation suppliers
- Research and build knowledge about products, services, technology, test methods, and documents in the clearest, most logical way for greatest reader comprehension
- Drive continuous improvement (NCs and CAPAs) and assess current procedures, generate quality plans, and identify best practices
- Prepare for internal and external audits by gathering records, supporting back‑room activities, and providing explanations for design areas in the front room with auditors
- Fully support the Quality Policy by building quality into all aspects, maintaining compliance to all quality requirements, and supporting improvements that simplify compliance in complex areas
- Demonstrate extensive application of knowledge through delivery of high‑quality deliverables (SOPs, technical literature, work instructions, engineering work product) to ensure continuity of content style that meets applicable standards and is appropriate for its intended audience
- Show strong attention to detail, review and audit other technical publication deliverables, and consistently deliver quality documentation with no errors
- As regulations change and quality systems are merged/aligned, execute creation/refinement of department and quality system SOPs, work instructions, forms, and templates with considerable graphical content and minimal supervision
- Provide input to create training and communication materials that can be used by self or staff to convey new or updated processes
- Have experience modifying existing and creating new quality system documentation (work instructions, SOPs, forms, checklists, templates)
- Lead structured problem‑solving initiatives to resolve complex technical issues and document within appropriate quality system documentation
Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
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