Quality Assurance Manager

Sunnyvale, CA 94086

Employment Type: Direct Category: Quality Manager Job Number: 8087

Qualifications:

  • BS in Engineering or Sciences
  • Experience working in a formal precision machining/metal fabrication environment (contract manufacturer, precision machine shop) - strong quality control background, GD&T knowledge
  • Experience establishing a QMS (Quality Management System), implementing and maintaining it
  • Deep experience in part inspection using CMM (coordinate measurement machines) Zeiss, Mitutoyo...etc. as well as handheld tools (calipers, micrometers, gauges...etc.)
  • Experience in Lean initiatives, TQM, TQC, DOE, Statistical Process Control (SPC - Mini-Tab)
  • Experience in conducting Process Validation, Equipment Qualification, Supplier Qualification
  • Experience in CAPA, SCAR, ASL, NCR
  • Strong familiarity with ISO 13485 for medical devices, ISO 9001
  • Must be a hands-on management professional
  • Strong communications and leadership skills

Responsibilities:

  • Manage all qualities activities including managing the activities of 3 full time Quality Inspectors
  • Customer interface on quality related issues
  • Direct and conduct Process Validation  - IQ, OQ, PQ
  • Direct and facilitate quality audits - ISO audits, customer audits, OSHA audits, internal quality audits
  • Direct and conduct quality control activities - incoming inspection, in-process inspection, final inspection, C of C, C of A
  • Works side by side with quality/inspection staff to ensure successful customer experience

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