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Quality Engineer

Job in Carlsbad, San Diego County, California, 92002, USA
Listing for: Katalyst CRO
Seasonal/Temporary position
Listed on 2025-12-01
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering, QA Specialist / Manager
Job Description & How to Apply Below

Join to apply for the Quality Engineer role at Katalyst CRO

We are seeking a Quality Engineer to join our team. The successful candidate will participate in Suppliers' and contract manufacturers' performance scorecards, coordinate QMS audits, and manage Quality Management system activities.

Responsibilities
  • Participate in Suppliers' and contract manufacturers' performance scorecards as required.
  • Coordinate and execute 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.
Requirements
  • Minimum 5 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 (i.e. Word, PPT, etc.)
  • ISO Led auditor/Auditor certified preferred.
  • ISO 9001 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.
Other Information
  • Seniority level:
    Associate
  • Employment type:

    Contract
  • Job function:
    Quality Assurance
  • Industries:
    Pharmaceutical Manufacturing
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