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Electrical Engineer Quality
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  • You will work closely with operations and the business functions to ensure quality performance of product and processes.
  • You will collaborate with divisional QA and supplier teams to address top quality issues cross functionally
  • You will own identified internal and supplier non-conformances and manage the timely closure of NC's.
  • You will own identified internal CAPAs and manage to timely root cause investigation, implementation, and closure.
  • You will disposition non-conforming product within MRB, issuing NC's as appropriate.
  • You will develop and improve internal manufacturing processes for existing products.
  • You will perform PPAP activities for supplier changes
  • You will maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
  • You will support and drive Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
  • You will engage and interface in internal and external audits providing subject matter expertise
  • You will support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
  • You will be responsible for initiation, internal containment, and support of Commercial Holds for potential product escapes.
  • Bachelor's degree in Engineering or related discipline (Electrical Engineering highly preferred)
  • 0+ years of experience in quality and/or manufacturing engineering a must
  • Experience in electronics (PCBAs, flex boards, soldering, etc.) highly preferred
  • Production process controls experience preferred
  • Validation knowledge/experience (PPAP, IQ/OQ/PQ) preferred
  • MS, CQE, or CRE preferred.
  • Six Sigma Green or Black belt preferred.
  • Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.

Katalyst HealthCares & Life Sciences Inc

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