COMPANY INFORMATION*** Inc. (NYSE: TMO) is the world leader in serving science, with revenues of *** billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.
We are looking for innovative candidates to be a key contributor in supporting the development of software product that impact on patient lives. The candidate will support R&D with primary responsibility for the hands-on management of documentation supporting software diagnostics product development and on-market product improvements. This candidate will work closely with cross-functional teams to write, edit, review and finalize technical documents required for software products which includes but not limited to documents involving design control deliverables, verification and validation protocols and reports, and other documents associated with the phase-gate development of new products and the transfer of products from R&D to production.This technical writer role will be a trusted resource and a key core team member in a multi-functional, multi-site project team. This position will be responsible for developing the documents for the software application according to IEC 62304 and 21 CFR Part 11 environment.
• Follow design control for new software product development per FDA and international guidelines
• Build Design History File for new software product development
• Develop design control documentation, including Design and Development Plans, Development Reports, Test Method and Process Validation Protocols, FMEAs
• Manage document change control
• Develop Standard Operating Procedures
• Maintain integrity of documents to comply with and be incorporated into the company's quality procedures. High quality, well formatted, clear documentation following GDP (good documentation practices) is mandatory.
• Development of customer-facing documentation e.g. user guides, training manuals
• Solicit, align, and incorporate feedback from diverse stakeholders.
Bachelors in related field plus 5 year of experience
• Excellent verbal and written communication skills
• Skills in Microsoft Office
• Ability to work in a fast paced environment
• Ability to drive project progress per assigned task
• Must be highly collaborative, have the ability to work within a diverse team, and contribute to a supportive, positive work environment both within the team and in the greater site-wide community
• Knowledge of FDA regulations for software product development
• Translates software user needs pr
Verification And Validation (Software)
Title 21 Of The Code Of Federal Regulations