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Senior Supplier Quality Engineer
Senior Supplier Quality EngineerASP Global • Austell, GA, US
Senior Supplier Quality Engineer

Senior Supplier Quality Engineer

ASP Global • Austell, GA, US
6 days ago
Job type
  • Full-time
Job description

Overview

We are seeking a Senior Supplier Quality Engineer with deep expertise in medical devices to serve as a collaborative quality liaison between our diverse supplier partners (Contract Manufacturers, OEMs, Service Providers, etc.) and internal teams such as Product Development, Regulatory, Procurement, and Sourcing. This role ensures alignment across stakeholders to maintain and enhance quality across the supply chain, through timely audits, supplier performance evaluations, issue resolution, and continuous improvement, all in accordance with regulatory standards.

Essential Duties And Responsibilities

Supplier Management & Development

  • Lead supplier selection, qualification, and requalification processes, including audits and on-site assessments, to verify compliance with quality system requirements (e.g., FDA QSR 21 CFR 820, ISO 13485, ISO 14971).
  • Develop, approve, and manage Supplier Corrective Action Requests (SCARs), Supplier Change Assessments (SCAs), and Supplier Quality Agreements (SQAs).
  • Monitor and evaluate supplier quality metrics (e.g., defect rates, on-time delivery), maintain scorecards, and communicate risks and opportunities for improvement.
  • Support supplier growth through training, process validations (IQ / OQ / PQ / Test Method Validation), and enhancements to supplier QMS and manufacturing processes.

Quality Systems & Compliance

  • Manage Non-Conforming Reports (NCRs), CAPAs, Document Change Orders (DCOs), and escalation through the Material Review Board (MRB).
  • Serve as a quality contact during internal and external audits, including those by regulatory bodies (e.g., FDA, Notified Bodies), and represent quality during supplier / site inspections.

    • New Product Introduction & Transfers

  • Collaborate cross-functionally with Product Development and Sourcing teams throughout new product development, supplier onboarding, M&A integrations, and manufacturing transfers.

    • Risk Management & Continuous Improvement

  • Use statistical tools and Six Sigma methodologies to monitor supplier performance and drive ongoing quality improvements.
  • Review and approve supplier technical documentation, including risk analyses, process validations, and specifications.
  • Lead investigations to identify root causes and implement corrective actions for complex supplier-related quality issues.

    • Seniority level

  • Mid-Senior level

    • Employment type

  • Full-time

    • Job function

  • Quality Assurance

    • Industries

  • Medical Equipment Manufacturing

    • J-18808-Ljbffr

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    Supplier Quality Engineer • Austell, GA, US