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Technical Writer II
1 month ago
Job Title: Technical Writer II
Job Type: 12+ months (Possibilities of Extension and convertible into full- time )
Location: Fremont,California,94538
Pay rate:$45 /Hourly on W2 + W2 Benefits
Shift: M-F (40/hrs/week)
Job Description: Position Summary:
The Technical Writer II is responsible for supporting the Quality Assurance and Regulatory Affairs teams by creating, revising, and maintaining documentation related to IVDR submissions. This role works cross-functionally with Manufacturing, Operations, and Project Management teams to address documentation gaps, revise documents, submit ECOs, and maintain project timelines to meet regulatory compliance requirements.
Job Responsibilities
• Work cross-functionally with other teams to create or revise documentation via the established document control process.
• Review and recommend revisions or changes in scope, format, and content to existing documentation. Maintain records and files of work and revisions.
• Work closely with Quality Assurance to ensure documentation implemented is compliant with regulatory requirements.
• Maintain strict compliance with Quality Management System requirements, ISO 13485, cGMP, QSR and other applicable regulations and/or standards.
• May be called upon the implement procedural changes supporting continuous improvement initiatives.
• Respond to Quality action related to CAPAs, SCARs or nonconformances.
• Proof-read and provide feedback on documentation prepared by other departments.
• Organize large amounts of technical information utilizing Advanced MS Word and Excel functions as well as manage many technical documents simultaneously.
• Ability to work independently and collaborate with cross functional teams to identify appropriate content updates as required.
• Participate in cross functional documentation projects as required.
• Keep functional leadership and/or project management appraised project status.
• Additional tasks as assigned.
Ideal Candidate Preferred Qualifications
• Effective communication skills and the ability to collaborate with cross functional teams
• Education: B.S./B.A. in a scientific discipline (e.g. chemistry, chemical engineering, biology, bioengineering, etc.). Preference given to candidates with technical writing and scientific background.
• Experience (minimum): 2 - 5 years’ experience in a regulated environment (ISO 13485, FDA QSRs, GMP or IVDs)
• Ability to work independently with guidance from leadership, and as part of a team;
• Manage multiple activities, and adjust to changing priorities in a dynamic, FDA regulated environment.
• Strong attention to detail, and ability to understand technical terminology and complex processes.
• Experience in using an electronic Document Management System as a Technical Writer.
• Must be computer literate and competent in PC based software such as Office 2010 Professional (Word, Excel, Access, and PowerPoint).
• Must be organized and detail oriented to be able to prioritize own and other’s work and meet business productivity metrics.
• Proofreading and editing skills, and an aptitude for numbers and detail-oriented work requiring a high degree of accuracy.
• Must have excellent customer service and listening skills.
• Basic arithmetic skills including the ability to calculate figures and amounts and to interpret the data.
• Able to sit, stand and/or use keyboard for long periods of time.
Exact Schedule - M-F 8am-5pm
fully onsite
