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Quality Engineer I

Intellectt Inc
Temecula, CA Full Time
POSTED ON 8/4/2024 CLOSED ON 9/15/2024

What are the responsibilities and job description for the Quality Engineer I position at Intellectt Inc?

Hello I'm Komal from Intellectt we have an opening for a Quality Engineer I in Temecula, CA. Please find the job details and description below and if interested You can reach me at komal@intellectt.com or call me at 1(732)-813-9025.

Role: Quality Engineer I

Location: Temecula, CA - 92591

Duration: 8 Months

Shift Timings: 8 AM to 5 PM

Job Description

  • Identify internal requirements and external laws, regulations, guidance and standards (LRGS) applicable to one or more of division and quality systems
  • Ensure internal activities and external partnership activities meet applicable regulations and quality standards including FDA QSR and ISO 9001/ ISO 13485
  • Ensure external partnership activities meet applicable regulations and quality standards including FDA QSR and ISO 9001/ISO 13485
  • Interpret applicable internal requirements and external LRGS and incorporate into requirements for use in business processes internally or with external partners
  • Maintain and communicate monthly metrics
  • Review and approval of product design changes and Quality System documentation
  • Maintain external partner files
  • Create Quality System and/or external partnership related documents
  • Review external partnership assessment forms and assist in execution of onboarding and maintenance activities
  • Participate in external inspection/audit activities
  • Perform other duties as assigned by Management

Education And Experience

  • Bachelor's Degree in Life Sciences, Physical Sciences, Engineering discipline or equivalent technical
  • Minimum 0-2 years Quality Assurance experience
  • Minimum 0-2 years Medical Device manufacturing or pharmaceutical industries
  • Working Knowledge of applicable regulations and standards such as, FDA QSR and ISO 13485
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