Quality Assurance Specialist Job at Intellectt INC, Irvine, CA

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  • Intellectt INC
  • Irvine, CA

Job Description

Looking for:
A Quality Systems Analyst with experience in document control, supplier collaboration, and familiarity with medical device regulations. Ideal candidates should be capable of working with minimal supervision, have remote work experience, and be comfortable with cross-functional collaboration.



Technical skill:

  • Microsoft Power BI
  • SAP
  • Windchill
  • IQVIA
  • Microsoft Teams
  • General proficiency in Microsoft Office (Word including document markup)
Day-to-day responsibilities:
  • Document control (redlining, updating-not creating from scratch)
  • Handling change requests via Windchill and IQVIA
  • Supporting supplier decommissioning activities
  • Coordinating with suppliers regarding ISO certificates and quality agreements
  • Supporting data validation and setup for new software systems due to transition from Edwards to BD
  • Collaboration with Quality, Engineering, Purchasing, and Finance departments
  • Working with regulated indirect materials (high-level root cause involvement possible)


Education:
  • Bachelor's degree preferred
Experience:
  • Background in medical device or med-tech industry
  • Experience with quality assurance/document control
  • Supplier quality experience preferred but not required
  • QA Associates with relevant system experience will be considered
Top Skills:
  • Quality Systems knowledge (Windchill, IQVIA, SAP)
  • Document control and change management
  • Supplier collaboration
  • Ability to work remotely and independently
  • Strong communication and organizational skills

Job Tags

Work experience placement, Remote job,

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