Prismatik
Technical Writer - Manufacturing (Monday to Friday 8:00am to 5:00pm)
Prismatik, Irvine, California, United States, 92713
Essential Functions
Delivers high quality documentation and in-product text updates.
Generates protocols, technical reports, test methods, manufacturing instructions, project planning documents, and labeling documents.
Creates, updates, and maintains design history files, manufacturing bill of materials (BOM), routers procedures, bill of materials, travelers, and technical submission files.
Revises instructions for use (IFUs), files, manuals, brochures, and other documentation for updated or changed product information and procedures.
Analyzes technical documents meticulously to identify changes.
Submits copies to management for feedback.
Drafts and documents procedures and technical documentation from established notes, demonstrations, observations, and photographs.
Proofreads documents to ensure clarity, proper grammar, and spelling. Conforms to departmental style guidelines and ensures documentation meets the needs of the business and the audience.
Collaborates with internal team stakeholders to ensure alignment and execution of priorities. Participates in internal team discussions for ongoing feature work.
Coordinates with regulatory team on technical file submissions and approval process.
Coordinates, validates, and assists with documenting test results.
Utilizes document control system software.
Performs and/or supports internal and/or external audits as required.
Performs other related duties and projects as business needs require at direction of management.
Education and Experience
Minimum three (3) years of direct documentation experience in manufacturing or related industry.
Experience in working in dental or medical device industry as a technical writer.
Experience with the use of electronic document control systems such as ETQ or CatsWeb, a plus.
Knowledge of 21 Code of Federal Regulations (CFR) 820 a plus.
Experience working in a Food & Drug Administration (FDA) regulated industry, a plus.
Experience with industry standards such as American Society for Testing and Materials (ASTM), American National Standards Institute (ANSI) and International Organization for Standardization (ISO) a plus.
Pay Range: $28.50 to $36.00/hr
Exact compensation may vary based on skills and experience.
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Delivers high quality documentation and in-product text updates.
Generates protocols, technical reports, test methods, manufacturing instructions, project planning documents, and labeling documents.
Creates, updates, and maintains design history files, manufacturing bill of materials (BOM), routers procedures, bill of materials, travelers, and technical submission files.
Revises instructions for use (IFUs), files, manuals, brochures, and other documentation for updated or changed product information and procedures.
Analyzes technical documents meticulously to identify changes.
Submits copies to management for feedback.
Drafts and documents procedures and technical documentation from established notes, demonstrations, observations, and photographs.
Proofreads documents to ensure clarity, proper grammar, and spelling. Conforms to departmental style guidelines and ensures documentation meets the needs of the business and the audience.
Collaborates with internal team stakeholders to ensure alignment and execution of priorities. Participates in internal team discussions for ongoing feature work.
Coordinates with regulatory team on technical file submissions and approval process.
Coordinates, validates, and assists with documenting test results.
Utilizes document control system software.
Performs and/or supports internal and/or external audits as required.
Performs other related duties and projects as business needs require at direction of management.
Education and Experience
Minimum three (3) years of direct documentation experience in manufacturing or related industry.
Experience in working in dental or medical device industry as a technical writer.
Experience with the use of electronic document control systems such as ETQ or CatsWeb, a plus.
Knowledge of 21 Code of Federal Regulations (CFR) 820 a plus.
Experience working in a Food & Drug Administration (FDA) regulated industry, a plus.
Experience with industry standards such as American Society for Testing and Materials (ASTM), American National Standards Institute (ANSI) and International Organization for Standardization (ISO) a plus.
Pay Range: $28.50 to $36.00/hr
Exact compensation may vary based on skills and experience.
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