Senior Supplier Quality Engineer — Parts Qualification Lead

Intellectt Inc; Minnesota; On-site; USD 110,000 - 160,000; Full time

Job summary

Intellectt Inc. is seeking a Senior Supplier Quality Engineer to lead supplier qualification efforts for critical components, working with R&D, Design Assurance, Operations, Regulatory, and supplier development teams.

The role emphasizes proactive leadership in a fast-paced, on-site environment to meet development and launch timelines. You will drive gage studies, process validations, and test method development, while coordinating CAPAs and SCARs with external suppliers and internal

Qualifications

• Experience with FDA/ISO quality systems and regulatory requirements.
• Proven ability to lead qualification and validation activities.
• Strong data analysis and problem solving skills.
• Ability to communicate quality risks to leadership.

Responsibilities

• Lead gage studies, process capability studies, and supplier validations.
• Develop and validate inspection methods and fixtures; use SolidWorks for fixtures.
• Support Receiving Inspection with test methods and investigations.
• Manage supplier corrective actions from start to finish.
• Report supplier qualification status at cross-functional meetings.
• Analyze quality metrics for Supplier Quality.

Skills

FDA 21 CFR 820/ISO 13485

Design Controls

Statistical methods

Gage R&R/SPC

Root cause analysis

GD&T reading

CAPA management

Tools

SolidWorks

Job description

Intellectt Inc. is seeking a Senior Supplier Quality Engineer to lead supplier qualification efforts for critical components, working with R&D, Design Assurance, Operations, Regulatory, and supplier development teams.

The role emphasizes proactive leadership in a fast-paced, on-site environment to meet development and launch timelines. You will drive gage studies, process validations, and test method development, while coordinating CAPAs and SCARs with external suppliers and internal