What are the responsibilities and job description for the Medical Device Technical Writer: 25-03652 position at Akraya Inc.?
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 :
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
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Salary : $60 - $65
