Supplier Quality Engineer

Katalyst CRO; Plymouth (MN); On-site; USD 80,000 - 100,000; Full time

Job summary

Katalyst CRO in Plymouth, Minnesota is looking for an experienced Supplier Quality Engineer. The role involves driving supplier quality and inspection activities, collaborating with design engineers, and supporting qualification processes.

The ideal candidate will have over 5 years of experience in the Medical Device industry, with knowledge of FDA regulations and hands-on experience in quality engineering. You will play a crucial part in ensuring product reliability and manufacturability.

Qualifications

• 5+ years of experience in Manufacturing Engineering, Supplier Quality, or Quality Engineering within Medical Devices.
• Hands-on experience with Supplier Quality Engineering and receiving inspection.
• Experience developing inspection procedures and quality plans.

Responsibilities

• Drive supplier quality and incoming inspection activities.
• Analyze material non-conformances and work with suppliers on resolution.
• Support component selection, qualification, and reliability assessments.

Skills

Supplier Quality Engineering

Material non-conformance analysis

Collaboration with Design Engineering

Manufacturing Engineering experience

Knowledge of FDA regulations

Education

5+ years in Manufacturing Engineering or related fields

Tools

SAP

Windchill

Job description

Overview

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.

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