Supplier Quality Engineer jobs in United States
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Illumina · 1 day ago

Supplier Quality Engineer

Illumina is a company dedicated to expanding access to genomic technology for health equity. The Supplier Quality Engineer will be responsible for ensuring compliance with quality regulations and improving product quality by managing supplier relationships and driving quality improvements.

BiotechnologyGeneticsHealth CareMedical
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Responsibilities

Lead or provide support to investigations to determine root causes on material quality issues and initiate/ensure corrective and preventive action plans are developed and executed
Interface with Suppliers/CM (Contract Manufacturer), Engineering/ Manufacturing/ Quality Assurance/ Procurement departments to drive for quality improvements, specifically on incoming rejects, workmanship defects and primitive failures
Drive Quality review with supplier/CM for improvement to meet quality expectation
Constantly review quality processes and suggests improvements that can be implemented to improve performances
Manage Supplier/CM through continuous improvement activities
Compile and evaluate supplier/CM quality performance metrics
Ensure that supplier’s preventive and corrective action is implemented and effective
Provide monthly quality data/input for suppliers/CM’s Scorecard
Responsible for the qualification processes for suppliers, including new supplier evaluation, audit programs and supplier approval programs
Work closely with Procurement and Engineering departments to identify new suppliers for evaluation
May be involved in providing training
Other such duties that may be determined by Management

Qualification

Supplier managementSupplier auditsFDA regulationsISO 13485Quality toolsStatistical analysisWell organizedDetail-orientedTeamwork

Required

Experience in managing Contract Manufacturer/Suppliers
Experience in conducting supplier audits
Good understanding of FDA regulatory environment (CFR 820), 501k and ISO 13485 strongly preferred
Developing basic knowledge of FDA Quality System Regulations and/ or ISO 13485 Standard
Developing basic knowledge of quality tools
Beginning to intermediate experience with words processing and spreadsheets, charting, graphing tools and presentation tools
Must be detailed oriented, well organized and able to work independently and in teams
Typically requires B.S. degree and 0 to 2 years of experience, or additional experience in lieu of degree

Preferred

Experience in medical device/ pharmaceutical/ IVD is preferred
May have experience with electronic production life (PLM), enterprise resource planning tools (SAP) and etc
May have experience with statistical analysis packages, eg, JMP, minitab

Benefits

Access to genomics sequencing
Family planning
Health/dental/vision
Retirement benefits
Paid time off

Company

Illumina

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Illumina is an innovative technology and revolutionary assays aiming the analyze genetic variation and function.

Funding

Current Stage
Public Company
Total Funding
$1.28B
Key Investors
Bank of America
2024-09-06Post Ipo Debt· $500M
2023-01-04Post Ipo Debt· $750M
2000-07-28IPO

Leadership Team

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Steven Barnard
Chief Technology Officer, Head of Research & Product Development
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Jenny Lei Zheng
SVP & GM of Greater China
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Company data provided by crunchbase