Quality Assurance Specialist

5 days ago


Milpitas, California, United States USI Full time
USI Quality Engineer Job Description

Job Title: Quality Engineer

Job Summary: We are seeking a Quality Engineer to join our team in Milpitas, CA. The ideal candidate will ensure the safety and quality of our products and procedures through rigorous inspections and quality control measures.

Responsibilities:

  • Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
  • Work with manufacturing engineer and sign off on IQ, OQ, PQ, PPAP, Advanced Product Quality Planning, and APQP, master validation plan (MVP) and device manufacturing history and tracking data.
  • Lead the customer's complaint and initiate a CAPA.
  • Perform data trend analysis, participate in Phase Reviews, write Quality Procedures, perform data/statistical analysis.
  • Lead the customer QBR's to present and explain quarterly quality results.
  • Verify data integrity, revision level, ECO, ECR, deviations, process alert, and data sheet validations.
  • Audit our systems based on ISO requirements.
  • Determine and sign off quality metrics for all manufacturing process instructions.
  • Ensure the necessary training is done and documented.
  • Communicate closely with customers. monitor the entire production cycle and perform regular reviews to identify potential malfunctions as early as possible.
  • Identify the root cause of technical issues and recommend fixes and use quality tools to find the root cause of problems.
  • Perform pFMEA with all departments to identify the risk and the mitigation plan.
  • Initiate internal and external 8D CAPA and SCARS. Led the team to close internal CAPAs and external SCARS.
  • Be familiar with non-conformance, RMA, and MRB
  • Set and track quality goals by analyzing SPC, CP, CPK, and G R & R calculations.
  • Read and be familiar with customers' electronics, electrical, and mechanical blueprints.
  • Act as a leader to work with internal teams to increase customer satisfaction by improving the quality of the products, including inspections of materials and customer's product assemblies.
  • Be flexible if other duties as assigned.

Minimum Qualifications:

  • BS degree level of knowledge that would be obtained from a BS degree
  • 2-5 years of experience as a quality engineer in an electronic manufacturing environment

Key Competencies:

  • Attention to detail
  • Problem-solving skills
  • Leadership
  • Engagement
  • Communication
  • Teamwork
  • Training skills
  • Speaking and writing fluently in English
  • Experience with quality standards, including the following:
    • ISO 9001
    • ISO 13485
    • TS 16949
    • ISO 14001
    • IPC-610 Workmanship Standards
    • J-STD-033A (MSD Handling)
    • ANSI/ESD S20.20-2014
    • PPAP
    • APQP
    • MVP


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