Job Summary:
Prismatik Dentalcraft is a division of Glidewell Dental, and they are seeking a Technical Writer to generate and maintain technical documentation for their products. The role involves collaborating with R&D and project management to support product launches and ensuring compliance with ISO and other applicable standards.
Responsibilities:
• 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.
Qualifications:
Required:
• 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.
• Knowledge of 21 Code of Federal Regulations (CFR) 820.
• Experience working in a Food & Drug Administration (FDA) regulated industry.
• Experience with industry standards such as American Society for Testing and Materials (ASTM), American National Standards Institute (ANSI) and International Organization for Standardization (ISO).
Company:
PRISMATIK DENTALCRAFT, INC. is a Glidewell Dental company. Founded in 2005, the company is headquartered in Newport Beach, California, US, , with a team of 501-1000 employees. The company is currently Late Stage.