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Technical Writer

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- Develop design control documentation, including - Design and Development Plans, Development Reports, Test Method and Process Validation Protocols, FMEAs 
- Develop and update Manufacturing procedures, QC procedures, and other documents from a Device - Master Record (DMR) 
- Manage document change control 
- Regularly interact with subject matter experts and attend project team meetings 
- Manage documentation review and approval: - Proactively solicit and rapidly incorporate feedback from other functions (QA, RA, R&D, MFG, etc). 
- 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. 
- Work with minimal supervision and manage time effectively 
- Deliver under tight deadlines 
- Identify and communicate risks to project deadlines in advance 
- Adapt to changes in project priorities 
- Any other duties as required for the role 


Minimum Requirements/Qualifications: 
- M.S. degree in a life science (biomedical) or quality field. 
- A minimum of 3 years of experience supporting IVD products, including writing Design Control documentation and DMR documentation. 
- Experience in Molecular Diagnostics preferred 
- Advanced knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook, etc.). 
- Strong experience in Design Control, ISO 13485, and - 21 CFR Part 820 Quality Systems Regulation. 
- Quick learner, thorough understanding of presented technical/scientific content. 
- Ability to write clearly, concisely, accurately, and quickly under tight deadlines. 
- Keen attention to detail and high regard for quality. 
- Experience working in a self-driven, performance/results oriented, fast paced matrixed environment. 
- Willingness to take on new challenges. 
- Able to adapt to changing needs caused by time, budget, or other constraints. 
- Excellent problem solving skills, including issue resolution. 
- 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 community

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