Technical Writer - R&D na Glidewell Dental
Glidewell Dental · Irvine, Estados Unidos Da América · Onsite
- Professional
- Escritório em Irvine
Essential Functions:
- Generates, maintains, and updates protocols, technical reports, test methods, manufacturing instructions, project planning documents, and labeling documents.
- Creates and maintains design history files, manufacturing bill of materials (BOMs),routers and labels.
- Creates memos, marketing documents, instructions for use (IFUs), and labels according to the Quality System.
- Collaborates with Research &Development (R&D) and project management team to determine project action items, documentation, and meeting schedules to support product launches.
- Prepares project-related documentation such as project plans; utilize D365 or similar platforms to create part lists etc.
- Creates, maintains, and updates procedures.
- Assists in the preparation of technical manuscripts, white papers, and patent documentation. Works closely with R&D teams to ensure clarity, accuracy and alignment with publication and intellectual property requirements.
- Collaborates with engineers, scientists, regulatory and quality staff in the company to ensure accuracy and completeness of all documentation.
- Support internal regulatory requirements related to documentation and on assigned projects.
- Ensures all testing procedures and documentation comply with ISO, ASTM and other applicable standards.
- Provides documentation in support of internal and external audits, and knowledge transfer activities.
- Performs other related duties and projects as business needs require at direction of management.
Minimum Qualifications:
- Associate’s degree in a scientific or engineering field with a minimum of four (4) years of technical documentation experience; or Bachelor’s degree in a scientific or engineering field with a minimum of two (2) years of technical documentation experience.
- 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: $30.44-$40.58/hr
Exact compensation may vary based on skills and experience.
This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available.
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