Quality Engineer

1 month ago


Temecula, United States Futran Tech Solutions Pvt. Ltd. Full time
Title - Quality Engineer

Location - Temecula, CA(Onsite)

Roles & Responsibilities:
  • Identify internal requirements and external laws, regulations, guidance and standards (LRGS) applicable to one or more of division's 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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