Lead Supplier Quality Engineer - Medical Devices

Katalyst CRO; Plymouth (MN); On-site; USD 95,000 - 115,000; Full time

Job summary

Katalyst CRO in Minnesota is seeking an experienced Supplier Quality Engineer to support supplier quality initiatives, incoming inspection, and manufacturing quality programs within the medical device sector.

You will drive supplier quality, analyze non-conformances with suppliers, review component quality, and lead CAPA investigations and corrective actions in collaboration with Design Engineering and suppliers.

Qualifications

• 5+ years 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 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.

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.

Skills

Supplier Quality

CAPA

Root Cause Analysis

Quality Assurance

Tools

SAP (Quality/Supply Chain modules)

Windchill

Job description

Katalyst CRO in Minnesota is seeking an experienced Supplier Quality Engineer to support supplier quality initiatives, incoming inspection, and manufacturing quality programs within the medical device sector.

You will drive supplier quality, analyze non-conformances with suppliers, review component quality, and lead CAPA investigations and corrective actions in collaboration with Design Engineering and suppliers.