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Supplier Quality Engineer

Karwell Technologies

Plymouth, MN

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JOB DETAILS
SKILLS
Bill of Materials (BOM), Change Control, Change Management, Component Selection, Control Systems, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Document Control, ERP (Enterprise Resource Planning), FDA Requirements, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Machine Tool, Manufacturing, Manufacturing Engineering, Materials Analysis, Medical Equipment, Procedure Development, Product Design, Product Reviews, Quality Assurance, Quality Engineering, Receiving Inspection, Reliability Analysis, Root Cause Analysis, SAP, Supply Chain, Technical/Engineering Design, Validation Testing, Vendor/Supplier Evaluation, Vendor/Supplier Management, Windchill PLM Software
LOCATION
Plymouth, MN
POSTED
3 days ago

Job Description:
We are seeking an experienced Supplier Quality Engineer with a strong background in the Medical Device industry to support supplier quality, incoming inspection, and manufacturing quality initiatives.

Roles & responsibilities :

  • Drive supplier quality and incoming inspection activities
  • Analyze material non-conformances and work directly with suppliers on resolution
  • Support component selection, qualification, and reliability assessments
  • Review product designs for quality and manufacturability
  • Lead supplier investigations, root cause analysis, and corrective actions

Education & Experience :

  • 5+ years of experience in Manufacturing Engineering, Supplier Quality, or Quality Engineering within Medical Devices.
  • Hands-on experience with Supplier Quality Engineering, Receiving Inspection, and supplier management.
  • Experience with SAP (Quality/Supply Chain modules) or similar ERP systems
  • Knowledge of Windchill or other document control systems for change management and BOM updates.
  • Experience developing inspection procedures, quality plans, and inspection tooling.
  • Ability to support component qualification, testing, validation, and approval activities.
  • Strong collaboration with Design Engineering on component quality, reliability, and manufacturability.
  • Experience investigating supplier-related quality issues, material defects, and corrective actions (CAPA).
  • Knowledge of FDA regulations, GMP, ISO 13485, and ISO 14971.

About the Company

K

Karwell Technologies

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