Quality Engineer

San Jose, CA 95131-1126

Employment Type: Direct Category: Quality Engineer Job Number: 7901

Qualifications:

  • BSME or Bachelor's in scientific field
  • Experience as quality engineer
  • Familiar with ISO 13485 and FDA regulations
  • Experience with CAPA and quality auditing 
  • Experience with validating is a plus
  • Proficient in Microsoft Office (MS Visio is a plus)
  • Occasional travel required 

Responsibilities:

  • Implement CAPA interacting with individuals and departments; evaluate effectiveness of corrective/preventative actions
  • Perform internal and supplier audits; issue Supplier Corrective Action Requests 
  • Create validation documentation to be executed in Master Validation Plan
  • Ensure projects adhere to regulatory compliance (QSR, FDA) and meet customer requirements
  • Create external customer communications, field corrections
  • Perform quality and safety training for staff

 

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