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Quality Engineer

Quality Engineer

Katalyst HealthCares & Life SciencesCarlsbad, CA
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Responsibilities :

  • Participate in Suppliers' and contract manufacturers' performance scorecards as required.
  • Coordination and execution of QMS audits (Internal and Vendor) as required.

Act as Quality representation for product innovation processes as directed by the Quality Director.

  • Coordinate the calibration and preventive maintenance processes of the measurement devices in all client sites.
  • Manage all Quality Management system activities including CAPA, Management Review, and Document Control.
  • Conduct failure analysis on returned products.
  • Support client WH and VAS centre regarding work instructions and process definition.

    • Other duties as assigned.

    Requirements :

  • Minimum years of working experience as a Quality Engineer in a manufacturing environment.
  • Experience in ISO Quality Systems Implementation and Management.
  • Bachelor's degree or equivalent work experience in a Manufacturing environment.
  • Strong knowledge of MS Excel and skills in other Microsoft applications ( Word, PPT, etc.)
  • ISO Led auditor / Auditor certified preferred.
  • ISO Quality System Managements.
  • PPAP, FMEA, SPC, Lean-Six Sigma methodologies.
  • Strong analytical skills to identify the source of problems and to propose solutions.
  • Strong organizational and communication skills.
  • Ability to multi-task and meet deadlines.
  • Demonstrated time management skills.
  • Strong attention to detail.
  • Positive attitude, self-motivated and eager to succeed.
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    Quality Engineer • Carlsbad, CA