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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):

 

 

Position Summary:


Essential Duties and Responsibilities:

  • 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