Technical Writer

About the position

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent that's bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com. Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene's high-speed growth. We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Responsibilities

• Author, format, store, and update various technical documents, including Standard Operating Procedures (SOPs), Work Instructions, and Engineering Protocols.
• Ensure all written materials align with company, quality, and FDA guidelines across all manufacturing components.
• Manage all the existing and incoming equipment and ensure their documentation using the equipment binder.
• Perform risk assessments, investigate nonconformance issues, gap analysis, and develop corrective actions.
• Initiate and manage Change Requests and Change Orders to validate new and repaired equipment.
• Serve as the main focal point for the component system, including data collection, data validation, meeting coordination, rollout execution, and progress updates.
• Support Maintenance and Repair schedules with sufficient documentation for each piece of equipment.

Requirements

• Bachelor's Degree
• 3+ years' experience in Technical Writing for Medical devices
• Strong understanding of ISO 13485, ISO 14971, FDA QSR - 21 CFR Part 820
• Good understanding of regulatory compliance for medical devices
• Ensure all documents conform to FDA requirements for GMP/QSR and ISO13485
• Professional experience writing technical documentation for both hardware and software in a FDA regulated environment
• Ability to read and interpret engineering drawings, design and risk documents, software requirements
• Exceptional written, organizational, inter-personal, project management, attention to detail and proofreading skills
• Proven ability to work independently and in teams
• Strong interpersonal, verbal communication, presentation skills and technical communication skills