Niktor LLC
Location
Fremont, CA | United States
Job description
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.
Additional Sills:
Skills:
Category
Name
Required
Importance
Experience
Job tags
Salary
