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Supplier Quality Engineer Jobs in Minnesota

Supplier Quality Engineer

Katalyst Healthcares & Life Sciences
  • Plymouth, MN
  • Instant Apply
30+ days ago

Job Description

Roles and Responsibilities:
  • Responsible for achieving a state of high-quality performance at our Supplier partners through the application and practice of Advanced Product Quality Planning 'APQP' , Supplier Qualification (Audit, Quality Agreement/Change Notice Agreement), and continuous monitoring the performance supplier to drive zero defect through Supplier Corrective Actions and notification.
  • You will fill a high-profile, cross functional position and play an integral role enabling development and production flow of Philips IGTD's critical supply base.
  • You will work in close coordination with Product Engineering, Supply Chain and Production and Suppliers to execute effective, creative and smart supply chain strategies to achieve production goals.
  • Perform Process Validation and Verification across Spectrawave IGTD portfolios for Consoles and Catheter parts.
  • Collaborate with R&D and Quality Design Assurance in Design for Manufacturability and Part Risk management per DFMAE and PFMEA.
  • Perform Process Validation , Verification, Test Method Validation, and assess CTS/CTQ criteria per APQP requirement for +700 parts.
  • Support Supplier Qualification including Audit, Quality Agreement and Change Notice Agreement.
  • Perform Problem solving in the case of FAI and APQP failure.
  • Deep dive Value Stream mapping across process.
  • Conducts thorough investigations of defects to determine if they are supplier-caused and implement corrections using the SCAR process.
  • Proactively manage, monitor, and troubleshoot supplier-related issues for quality of components, sub-assemblies, and assemblies includingmonitoring trends and managing Supplier Improvement and Supplier Quality Performance Monitoring.
  • Providing Quality oversight of product/process change requests from suppliers (SICRs: Supplier Initiated Chage Requests), ensuring appropriate regulatory review and adequate validation to support requested changes including following our APQP process and leading process validation, as necessary
  • Develop and oversee process validation plans, including equipment qualifications, with suppliers and lead continuous improvement projects based on process/product trends, customer complaints, industry standards, and government regulations.
Education and Experience:
  • Bachelor's degree engineering (Master Degree is plus).
  • 3+ years of engineering experience (Manufacturing Engineer and/or Product Quality is plus).
  • In-depth product manufacturing and quality experience in process validation and verification Subject Matter in IQ, OQ, PQ
  • SO, 13485 Lead Auditor certified is plus.
  • Experienced in plastic, metal, electronics commodities.
  • Strong written, oral and interpersonal skills to be able to effectively interface interdepartmentally and complete assignments with accuracy and a high attention to detail

Numbers & Facts

LocationPlymouth, MN

Skills

  • Advanced Product Quality Planning (APQP)unmatched
  • Auditingunmatched
  • Catheterizationunmatched
  • Change Requests/Ordersunmatched
  • Continuous Improvementunmatched
  • Corrective Actionunmatched
  • Cross-Functionalunmatched
  • Detail Orientedunmatched
  • Electronicsunmatched
  • Engineeringunmatched
  • Government Regulationsunmatched
  • Identify Issuesunmatched
  • Industry Standardsunmatched
  • Interpersonal Skillsunmatched
  • Manufacturingunmatched
  • Manufacturing Designunmatched
  • Manufacturing Engineeringunmatched
  • Performance Analysisunmatched
  • Presentation/Verbal Skillsunmatched
  • Problem Solving Skillsunmatched
  • Process Failure Mode and Effects Analysis (PFMEA)unmatched
  • Process Qualityunmatched
  • Process Validationunmatched
  • Product Engineeringunmatched
  • Quality Assuranceunmatched
  • Quality Assurance Methodologyunmatched
  • Quality Engineeringunmatched
  • Quality Managementunmatched
  • Quality Monitoringunmatched
  • Regulationsunmatched
  • Research & Development (R&D)unmatched
  • Risk Managementunmatched
  • Supply Chainunmatched
  • Validation Planunmatched
  • Validation Testingunmatched
  • Value Stream Mappingunmatched
  • Vendor/Supplier Evaluationunmatched
  • Vendor/Supplier Managementunmatched
  • Writing Skillsunmatched

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