Senior Supplier Quality Engineer - Life Sciences GMP

NCBioImpact

Mebane (NC)

On-site

USD 110,000 - 176,000

Full time

5 days ago
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Benefits offered by this job

Health & wellness benefits
401(k) retirement plan
Paid time off
Educational assistance

Job summary

Waters Corporation is seeking a Supplier Quality professional to guide supplier oversight and qualification within a regulated manufacturing setting. You will drive quality plans, risk analyses, and supplier development efforts across multiple commodities including electronics, optics, and assemblies.

You will partner with cross-functional teams to maintain design controls and quality system records, ensuring FDA/ISO compliance. Travel up to 20% is required in this global role.

Qualifications

  • B.S. or B.A. degree in an engineering or science field.
  • Minimum of 3 years of experience in Supplier Quality in a manufacturing environment
  • Experience in FDA or ISO regulated environments and quality systems.

Responsibilities

  • Provide guidance and Quality oversight for key suppliers to ensure compliance with Waters Quality, Regulatory and Industry standard requirements.
  • Drive and support new product development and sustaining activities in supplier management with design history documentation.
  • Provide quality support for Supplier Qualification and Approval steps including supplier selection and risk analysis.
  • Support Field Corrective Actions as needed.
  • Facilitate and partner with suppliers to develop strong business and quality relationships.
  • Establish initiatives to improve Supplier Quality Management Systems.

Skills

QSR/ISO/GMPs
Design Control
Product Risk Mgmt
CFR 820
Project management
Analytical thinking
Statistics & data analysis
SAP
Minitab
TrackWise
Quality systems software

Education

B.S./B.A. in engineering or science

Tools

SAP
Minitab
TrackWise

Job description

Waters Corporation is seeking a Supplier Quality professional to guide supplier oversight and qualification within a regulated manufacturing setting. You will drive quality plans, risk analyses, and supplier development efforts across multiple commodities including electronics, optics, and assemblies.

You will partner with cross-functional teams to maintain design controls and quality system records, ensuring FDA/ISO compliance. Travel up to 20% is required in this global role.

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