Akraya Inc.
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For more details, do connect with Michelle George at (408) 907-6609 or Michelle.George@akraya.com
JOB RESPONSIBILITIES:
Looking for a Technical Writer II to fortify our Quality Assurance and Regulatory Affairs teams through the generation, revision, and maintenance of crucial documentation pertaining to IVDR submissions. The ideal candidate will collaborate closely with Manufacturing, Operations, and Project Management teams to bridge documentation gaps, submit ECOs, and adhere to regulatory compliance deadlines. This role is pivotal in ensuring documentation compliance with Quality Management System requirements, ISO 13485, cGMP, QSR, and relevant regulations or standards, thereby contributing significantly to continuous improvement initiatives.
"Akraya is an award-winning IT staffing firm consistently recognized for our commitment to excellence and a positive work environment. Voted the #1 Best Place to Work in Silicon Valley (2023) and a Glassdoor Best Places to Work (2023 & 2022), Akraya prioritizes a culture of inclusivity and fosters a sense of belonging for all team members. We are staffing solutions providers for Fortune 100 companies, and our industry recognitions solidify our leadership position in the IT staffing space. Let us lead you to your dream career, join Akraya today!"
Technical Writer: 24-02082
Posted: 07/31/2024
2024-07-31
2024-09-04
Job Category: Business System / Financial / Business Analyst
Job Number: 22638966
Job Description
Primary Skills: Documentation, Regulatory Compliance, Technical Writing, ISO 13485/FDA QSRs
Contract Type: W2 Only
Duration: 12+ Months Contract
Location: Fremont, CA (94538) Onsite
Pay Range: $30.00 - $40.00 per hour
#IND1
For more details, do connect with Michelle George at (408) 907-6609 or Michelle.George@akraya.com
JOB RESPONSIBILITIES:
Looking for a Technical Writer II to fortify our Quality Assurance and Regulatory Affairs teams through the generation, revision, and maintenance of crucial documentation pertaining to IVDR submissions. The ideal candidate will collaborate closely with Manufacturing, Operations, and Project Management teams to bridge documentation gaps, submit ECOs, and adhere to regulatory compliance deadlines. This role is pivotal in ensuring documentation compliance with Quality Management System requirements, ISO 13485, cGMP, QSR, and relevant regulations or standards, thereby contributing significantly to continuous improvement initiatives.
- Collaborate with various teams to create or revise documentation, ensuring adherence to established document control processes.
- Conduct reviews, recommend revisions or changes in scope, format, and content of existing documents, and maintain accurate records and files.
- Coordinate with Quality Assurance to guarantee that documentation meets regulatory requirements.
- Maintain rigorous compliance with Quality Management System requirements, and relevant regulations and standards.
- Organize, proofread, and provide feedback on documentation, employing advanced MS Word and Excel functionalities.
JOB REQUIREMENTS:
- Proficiency in MS Office (Word, Excel, Access, PowerPoint) and electronic Document Management Systems.
- Strong attention to detail coupled with the ability to comprehend technical terminology and complex processes.
- Outstanding communication skills and the ability to work independently or as part of a team in a dynamic, FDA regulated environment.
"Akraya is an award-winning IT staffing firm consistently recognized for our commitment to excellence and a positive work environment. Voted the #1 Best Place to Work in Silicon Valley (2023) and a Glassdoor Best Places to Work (2023 & 2022), Akraya prioritizes a culture of inclusivity and fosters a sense of belonging for all team members. We are staffing solutions providers for Fortune 100 companies, and our industry recognitions solidify our leadership position in the IT staffing space. Let us lead you to your dream career, join Akraya today!"
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