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Supplier Quality Engineer

Karwell Technologies
  • Newark, DE
  • Instant Apply
30+ days ago

Job Description

Job Description:
  • Provide support to the Supplier Quality organization dedicated to the oversight of components, materials, and services.
  • Serve as a technical resource across the organization to ensure suppliers meet all quality, regulatory, and business requirements.
Roles & Responsibilities:
  • Conduct technical reviews of suppliers to assess their capability to manufacture materials and components.
  • Oversee, assess, and monitor supplier manufacturing processes, quality control practices, corrective actions, continuous improvement activities, and First Article Inspections (FAI).
  • Define and approve PPAP (Production Part Approval Process) requirements for new and revised purchased parts.
  • Collaborate with suppliers, Research & Development, and Design Assurance teams to ensure products meet fit, form, function, reliability, and quality requirements.
  • Issue, manage, and follow up on supplier quality events including SCARs, SACAs, and NCEs while monitoring workflow compliance with established KPIs.
  • Partner with suppliers to perform root cause investigations, problem solving, metrology assessments, and statistical analysis to prevent recurring failures.
  • Work with Post Market Surveillance, Quality Engineering, Manufacturing Engineering, R&D, and other cross-functional teams to resolve supplier-related complaints and quality issues.
  • Manage supplier-related nonconformities, containment actions, material disposition activities, and supplier sample returns as required.
  • Maintain complete and accurate supplier quality records.
  • Generate supplier performance metrics and reports to support stakeholder decision-making.
  • Qualify, coordinate, and execute activities associated with onboarding and implementation of new suppliers.
  • Utilize problem-solving tools such as SPC, TQM, and statistical sampling methodologies to optimize processes.
  • Ensure compliance with Medical Device Regulations, cGMP, CFR 820, ISO 13485, ISO 14971, ISO 9001, and applicable global regulatory requirements.
  • Support risk management activities, validation efforts (IQ, OQ, PQ), CAPA investigations, project management initiatives, and measurement system analysis (GR&R, AAA).
Requirements:
  • Bachelor's degree in an Engineering field from an accredited university.
  • Minimum 8 years of professional experience.
  • Medical Device industry experience required.
  • ISO 13485 Lead Auditor certification required.
  • Strong knowledge of Medical Device Regulations, cGMP, CFR 820, ISO 13485, ISO 14971, and ISO 9001.
  • Experience with risk management, CAPA, IQ/OQ/PQ validations, measurement system analysis (GR&R, AAA), SPC, statistical sampling, and PPAP.
  • Knowledge of project management techniques and global regulatory requirements (FDA, Canada, Brazil, Japan, etc.).

Numbers & Facts

LocationNewark, DE

Skills

  • Auditingunmatched
  • Code of Federal Regulationsunmatched
  • Continuous Improvementunmatched
  • Corrective Actionunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Cross-Functionalunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Decision Supportunmatched
  • FDA Requirementsunmatched
  • Failure Analysisunmatched
  • ISO (International Organization for Standardization)unmatched
  • ISO 9001unmatched
  • Maintain Complianceunmatched
  • Manufacturing Engineeringunmatched
  • Manufacturing/Industrial Processesunmatched
  • Medical Equipmentunmatched
  • Metrologyunmatched
  • Onboardingunmatched
  • Performance Analysisunmatched
  • Performance Metricsunmatched
  • Problem Solving Skillsunmatched
  • Process Improvementunmatched
  • Process Validationunmatched
  • Production Part Approval Process (PPAP)unmatched
  • Project/Program Managementunmatched
  • Purchasing/Procurementunmatched
  • Quality Controlunmatched
  • Quality Engineeringunmatched
  • Regulationsunmatched
  • Regulatory Complianceunmatched
  • Regulatory Requirementsunmatched
  • Research & Development (R&D)unmatched
  • Risk Managementunmatched
  • Root Cause Analysisunmatched
  • Statistical Samplingunmatched
  • Statisticsunmatched
  • Surveillanceunmatched
  • Systems Analysisunmatched
  • Total Quality Management (TQM)unmatched
  • Vendor/Supplier Evaluationunmatched
  • Vendor/Supplier Managementunmatched
  • Vendor/Supplier Selectionunmatched

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