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Senior Supplier Quality Engineer - Medical Device - Bay Area - Full Time

Company: Cambridge Recruiters
Location: Santa Clara
Posted on: January 10, 2022

Job Description:

Position OverviewThis Sr. Supplier Quality Engineer performs work with general supervision to provide and implement solutions to defined problems and assignments. The scope of responsibilities includes supporting manufacturing operations, managing suppliers, and working with cross-functional groups to address quality issues. The Supplier Quality Engineer II participates in decisions related to scope of work, risk management, process improvements, material disposition, and the implementation of revised product specifications. This position will require a passport and the ability to travel Internationally, up to 20% of the time.
Essential Job FunctionsSupplier Management:

  • Partner with Procurement, R&D, Operations, Quality, and Suppliers in the timely investigation, resolution, and prevention of supplier quality issues which could disrupt business operations
  • Monitor and analyze supplier performance metrics, identify improvement opportunities, and communicate supplier risks and/or opportunities to the next management level
  • Participate in the planning, scheduling, execution, and reporting of supplier audits
  • Participate in the initiation, issuance, review, and approval of Supplier Corrective Action Reports (SCARs)
  • Drive corrective actions for supplier processes by driving suppliers to true root cause analysis and corrective and preventive actions
  • Participate in component qualification change projects in collaboration with key business partners and the supplier's applicable functional groups
  • Compile, analyze, and summarize supplier performance data for Supplier Scorecards
    Manufacturing Support:
    • Review, investigate, disposition, and drive to completion Non-conforming Reports (NCRs) and Corrective and Preventive Actions (CAPAs)
    • Initiate, review, and approve Document Change Orders (DCOs)
    • Provide technical support and guidance to the Quality Control group
    • Collaborate with Manufacturing Engineering on process improvement projects
    • Investigate customer complaints and document investigation findings
    • Participate in internal and third-party audits (FDA, Notified Body)
    • Participate in Material Review Board (MRB) meetings
      Requirements
      • Must be fully bilingual in English and Spanish (speaking, reading and writing).
      • This position will require a passport and the ability to travel internationally up to 20% of the time
      • BS degree in a related engineering discipline and 3+ years of related experience, or MS degree in a related engineering discipline
      • Experience in the medical device industry is strongly preferred
      • Knowledge of cGMP, FDA 820 QSR, ISO 13485, or other Quality Systems
      • Strong technical writing skills
      • Effective communication skills across all levels of the organization
      • Must be proactive, self-motivated, and able to work independently with minimal supervision
      • Ability to work independently in a fast-paced environment while managing multiple priorities
      • Knowledge of statistics (hypothesis testing, capability analysis, DOE, MSA), Six Sigma, Lean
      • Certifications (CQE, Lead Auditor, Six Sigma, Project Management) would be a plus

Keywords: Cambridge Recruiters, Santa Clara , Senior Supplier Quality Engineer - Medical Device - Bay Area - Full Time, Engineering , Santa Clara, California

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