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Document Control QA Specialist

Company Name: ClearFlow, Inc.
Location: 140 Technology, Irvine
Job Type: QA/Documentation
Contact Name: Serrah Namini
Phone: 714-916-5014
Fax:
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: competitive based on Experience

Job Description (up to 200 words):

 

ESSENTIAL FUNCTIONS:     

    • Maintain and update Quality Records and documents
    • Document complaints, evaluations, and follow-ups
    • Support Quality/Engineering in documenting internal quality records, such as NCRs and CAPAs
    • Experience in regulatory affairs/ Quality and Medical device manufacturing is preferred 
    • Familiar with FDA Guidelines, and ISO 13485 
    • Knowledge and understanding of Quality and Regulatory concepts and application 
    • Strong analytical, planning and organizational skills
    • Strong interpersonal and communications skills (oral & written)
    • Self-starter with ability to work independently and react quickly to changing priorities
    • Proficient in MS Office products.
    • Program Management experience is plus