Quality Engineer

Newark, CA 94560

Employment Type: Contract Category: Quality Engineer Job Number: 8083

Qualifications:

  • BS in Engineering, Physical Science or Life Science
  • 5+ years of experience in Medical Device or Biotech/Life Science Instrumentation
  • ASQ certification (American Society for Quality), Six Sigma, QMS
  • Certification in Quality Engineer, Quality Auditor, Medical/Biomedical Auditor
  • Strong familiarity with regulated environments - FDA, ISO 13485, ISO 149771
  • Experience working with R&D product development teams to ensure compliant design control
  • Experience developing and conducting quality related training 

Responsibilities:

  • Support product development teams to customers' QMS and regulatory requirements
  • Create Quality Management Responsibilities Plans
  • Review and provide input to design team to ensure regulatory compliance
  • Provide quality perspective in risk management design activities
  • Review and approve DHFs (Design History File), DMRs (Design Master Record), DHRs (Device History Record)
  • Support vendor evaluation, qualification, perform supplier audits, CM audits
  • Support and provide quality guidance in all aspects of product development, QMS review, internal and supplier audits
  • Provide guidance for CAPA, root cause analysis, follow up and review processes for effectiveness

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