Technical Writer (ISO 13485)

Prismatik Dentalcraft is a division of Glidewell Dental

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.