Supplier Quality Engineer - Medical Device

PI Search

Athens (TX)

On-site

USD 75,000 - 110,000

Full time

2 days ago
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Job summary

PI Search in Athens, TX is seeking a Supplier Quality Engineer to strengthen supplier performance and incoming-quality systems at its Athens, Texas facility. This hands-on role will work directly with suppliers, resolving quality issues to closure and improving incoming inspection while partnering with Quality, Manufacturing, Engineering, and Procurement.

This onsite position requires the ability to live within commuting distance or relocate.

Qualifications

  • 3+ years of Quality Engineering experience.
  • Experience in an FDA- and ISO-regulated environment; medical-device and ISO 13485 experience preferred.

Responsibilities

  • Own supplier-quality activities, including SCARs, NCRs, supplier investigations, corrective actions, and follow-through to closure.
  • Build and maintain supplier scorecards using relevant performance measures.
  • Review and manage supplier notifications and changes; support the qualification and onboarding of new suppliers and materials.
  • Improve incoming-inspection processes, including process flow, inspection methods, equipment selection, sampling plans, and approved supplier/material controls.
  • Manage Dock-to-Stock and incoming AQL switching-rule programs based on supplier performance and risk.
  • Interpret engineering drawings, GD&T, and technical specifications to establish practical inspection requirements.
  • Conduct or support supplier and internal audits, inspections, investigations, and statistical analysis.
  • Work cross-functionally to improve product quality, material availability, and schedule adherence.

Skills

Supplier quality
SCAR/NCR processes
Incoming inspection
Statistical analysis
Audits
Engineering drawings
GD&T
Cross-functional

Tools

Inspection methods

Job description

A medical-device manufacturer is hiring a Supplier Quality Engineer to strengthen supplier performance and incoming-quality systems at its Athens, Texas facility. This is a hands-on role for someone who can work directly with suppliers, resolve quality issues to closure, improve incoming inspection, and partner effectively with Quality, Manufacturing, Engineering, and Procurement.

This position is fully onsite in Athens, Texas. Candidates must be able to live within a reasonable commuting distance or relocate.

  • Own supplier-quality activities, including supplier corrective action requests (SCARs), nonconformance reports (NCRs), supplier investigations, corrective actions, and follow-through to closure.
  • Build and maintain supplier scorecards using relevant performance measures.
  • Review and manage supplier notifications and changes; support the qualification and onboarding of new suppliers and materials.
  • Improve incoming-inspection processes, including process flow, inspection methods, equipment selection, sampling plans, and approved supplier/material controls.
  • Manage Dock-to-Stock and incoming AQL switching-rule programs based on supplier performance and risk.
  • Interpret engineering drawings, GD&T, and technical specifications to establish practical inspection requirements.
  • Conduct or support supplier and internal audits, inspections, investigations, and statistical analysis.
  • Work cross-functionally to improve product quality, material availability, and schedule adherence.
  • 3+ years of Quality Engineering experience.
  • Experience in an FDA- and ISO-regulated environment; medical-device and ISO 13485 experience are strongly preferred.
  • Hands-on experience with supplier quality, incoming inspection, audits, inspections, and statistical analysis.
  • Ability to read engineering drawings and apply GD&T and technical specifications.
  • Experience with SCAR/NCR processes, supplier performance management, and supplier change control.
  • CQE and/or CQA certification preferred.

Candidates must be authorized to work in the United States without current or future employer-sponsored work authorization. This is a five-day onsite position in Athens, Texas.

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