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Supplier Quality Engineer

Karwell Technologies

  • Newark, DE
  • 30+ days ago

    Highlights

    Work with Post Market Surveillance, Quality Engineering, Manufacturing Engineering, R&D, and other cross-functional teams to resolve supplier-related complaints and quality issues. Partner with suppliers to perform root cause investigations, problem solving, metrology assessments, and statistical analysis to prevent recurring failures.

    Numbers & Facts

    LocationNewark, DE

    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.).

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