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Medical Device Technical Writer
Ref No.: 20-03596
Category: Experienced Professional
Location: Mountain View, California
Position Type:Contract
Start Date / End Date: 07/13/2020 to 07/12/2021
Genesis10 is currently seeking a Medical Device Technical Writer with our client in the SEO industry in their Mountain View, CA location. This is a 12 month + contract position.

Description:
  • Seeking a Medical Device Technical Writer
  • This Technical Writer will be joining our Devices and Services Product Quality group to create high quality written content for technical documentation
  • This person will require attention to detail, and will be required to proofread, prepare, create, review, and edit documentation
  • This includes SOPs, work/testing instructions, validation documentation, technical reports, and record assessment reports
  • You will additionally be required to maintain a comprehensive library of technical terminology and documentation

Responsibilities:
  • Lead and/or participate in the development of new documents or update existing documentation used for new product development
  • Ensure consistency between documents by reviewing and editing for completeness
  • Rewrite documents to be accurate, clear and concise
  • Participate in the development and maintenance of document standards, naming/numbering conventions, and templates for Design History File (DHF) procedures, work instructions, and other relevant document types
  • Ensure that documents comply with established templates, formats and identification/naming/numbering standards
  • Support/manage document workflow and ensure compliance
  • Ensure that document reviews and approvals are managed in an efficient and effective manner
  • Assist in the identification and removal of old/obsolete procedures and work instructions, as required Manage and control specific quality records, as required

Requirements:
  • Bachelor's (Required) in a scientific or technical field
  • A minimum of 2 years of experience in document control or training, applying regulations and/or standards such: as FDA, ISO, etc.
  • Strong knowledge and experience in Professional Medical Writing (Medical/Clinical; Regulatory; and Safety)
  • This position requires the ability to interpret data from scientific literature and clinical studies and summarize the results and in a clear, concise, and scientifically accurate manner
  • Prior experience using gsuite, word processing, spreadsheet, and presentation software
  • Excellent written and verbal communication skills, possess a strong sense of responsibility and urgency
  • Strong process improvement mindset; passion for quality
  • Demonstrated effective interpersonal and effective teamwork skills
  • Analytical & problem-solving skills/root-cause analysis
  • Strong organizational skills with high attention to detail
  • Able to work as a W2 employee of Genesis10 (no Corp-to-Corp)
  • Desired:
    • Samples of technical procedures or work instructions or validation protocols scoped for medical devices

If you have the described qualifications and are interested in this exciting opportunity, please apply!
About Genesis10:
Genesis10 is a leading U.S. business and technology consulting firm with hundreds of clients needing proven talent and solutions to power their strategic initiatives. If you are a high performing business or IT professional with solid, referenced experience, we want to meet you. Genesis10 recruiters and delivery professionals are highly accomplished career advocates, who get to know you beyond your resume to position you with the opportunities that fit your skills, experience and aspirations. We have benefit options to fit your needs and a support staff that works with you from placement throughout your engagement project after project. To learn more about Genesis10 and to view all our available career opportunities, please visit us at www.genesis10.com. "Genesis10 is an Equal Opportunity Employer, M/F/D/V