Technical Writer - Central Coast - Tideri Jobbörse

Description

At First Line Software, we create a better world by finding innovative solutions to everyday problems.

We are a global team of over 500 professionals spread across the United States, Europe, Latin America, Australia, and India. We are looking for like-minded professionals who want to share their expertise and contribute to something meaningful.

The Project and Your Role

As a Technical Writer specializing in Design Control for a medical devices project, you will create comprehensive documentation, develop training materials, and establish best practices for efficient and compliant product development processes.

You will collaborate closely with various teams to ensure that Design Control procedures are accurately documented and communicated effectively throughout the organization.

Your Responsibilities:

• Design and implement training content for internal staff on Design Control processes and documentation best practices in alignment with regulatory requirements.
• Generate comprehensive documentation templates for Design Input/Output, Risk Management, Verification/Validation protocols, and other key Design Control documents.
• Work closely with subject matter experts to gather technical information and translate complex concepts into user-friendly training materials and procedural documents.
• Develop examples and case studies illustrating best practices in Design Control documentation to streamline product development and ensure adherence to quality standards.
• Maintain a repository of training resources, best practice examples, and document templates to support ongoing Design Control activities within the organization.
• Structure and organize the templates used for project documentation.
• Interact with quality assurance and compliance departments to standardize and streamline templates.
• Interview stakeholders to update and create a comprehensive template base.

You will also be responsible for complying with all safety policies, practices, and procedures, reporting unsafe activities to your supervisor and/or Human Resources, and participating in proactive team efforts to achieve departmental and company goals.

Requirements:

• Bachelor's degree in technical writing, engineering, or a related field.
• Proven experience in developing training content and documentation for Design Control processes in the medical device industry.
• Thorough understanding of regulations, ISO standards, and best practices in Design Control documentation.
• Expert ability to create structures and processes necessary to deliver enterprise programs/projects and/or new products to successful implementation.
• Proficiency in creating engaging and informative training materials, examples, and procedural documents.
• Strong communication skills and the ability to collaborate effectively with cross-functional teams.
• Familiarity with document management tools, eLearning platforms, and instructional design principles.