Senior Quality Engineer - Mechanical Engineer

San Jose, CA 95131-1126

Employment Type: Direct Category: Quality Engineer Job Number: 7966

Qualifications:

  • BSME or BSEE
  • 5+ years of experience in medical, biotechnology, or regulated industry
  • ProE or Solidworks/ 3D modeling
  • Experienced in product development or manufacturing (CAPA implementations)
  • FDA and ISO 13485 regulations
  • Interpret engineering drawings and specs

Responsibilities:

  • Maintain ISO and QSR compliance
  • Assist in creating inspection criteria in new product development, components 
  • Root-cause analysis, CAPA, SCARs - implement corrective action
  • Risk Management
  • V&V activities including design reviews, statistical analysis, FMEA meetings
  • Production process guidance
  • Supplier capability reviews and process controls

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