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    • Medical Device Technical Writer: 25-03652 - Sunnyvale - Akraya Inc.

    Akraya Inc.
    Akraya Inc. Sunnyvale

    2 days ago

    Default job background
    Description

    Primary Skills:

    • SOPs (Expert)
    • Regulations/Medical Devices (Advanced)
    • Document Control (Expert)
    • Excel/Smartsheet/OneNote (Intermediate)
    • Meeting Leadership (Advanced)

    Contract Type: W2

    Duration: 12+ Months

    Location: Sunnyvale, CA (Hybrid)

    Pay Range: $60 - $65 per hour on W2


    Job Summary:
    We are seeking two highly skilled QMS Technical Writers requiring 3-5 years of experience in a regulated environment, to develop and maintain clear, compliant, and user-friendly internal process documentation. The successful candidates will collaborate closely with cross-functional teams and SMEs, ensuring all documentation adheres to company and regulatory guidelines. This self-directed role demands excellent time management and communication skills, thriving in a fast-paced setting.

    Key Responsibilities:

    • Write, edit, and maintain internal process documentation in line with company and regulatory standards.
    • Provide writing support for teams transitioning to new templates and guidelines, developing process documentation flowcharts.
    • Ensure compliance with Quality, Document Control, and Good Documentation Practice (GDP) guidelines.
    • Act as lead writer on projects, mentoring other writers, keeping abreast of compliance requirements, sharing expertise, and participating in regulatory training.
    • Manage multiple project deliverables under tight deadlines, prioritizing effectively and collaborating with project teams.

    Must-Have Skills:

    • Exceptional writing, editing, and grammar skills in a regulated environment.
    • Strong organizational and time management capabilities.
    • Proficiency in Microsoft Word and Visio, with a solid understanding of Adobe Illustrator or Photoshop.

    Domain Experience: Previous experience in the medical devices sector or other regulated environments is required, highlighting a deep understanding of the document control process and familiarity with decision tracking software like OneNote, Excel, and Smartsheet

    About Us: Akraya is an award-winning IT staffing firm consistently recognized for our commitment to excellence and a thriving work environment. We were recently recognized as Inc's Best Workplaces 2024, Silicon Valley's Best Places to Work by the San Francisco Business Journal (2024), and Glassdoor's Best Places to Work (2023 & 2022)

    Akraya's Mission: As industry leaders in IT staffing, we connect you with great jobs and inspire you to reach your full potential.

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