Senior Supplier Quality Engineer – Med Device Quality Leader

Abbott; New Brighton (MN); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott in New Brighton, MN, seeks a Supplier Development Quality Engineer to lead supplier evaluation, qualification, and performance assessment. You will help develop and maintain supplier quality engineering methodologies, ensuring compliance with regulatory requirements.

You will guide purchasing, R&D, manufacturing and QA engineers, review supplier drawings and quality plans, and drive continuous improvement through data analysis, inspection procedures, and corrective actions.

Qualifications

• 5+ years of supply chain/operations experience.
• Medical device industry experience preferred.
• Demonstrated supervisory or leadership experience.
• Engineering background with quality tools/methodologies.
• Strong knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• Experience with SAP and maintaining master data integrity.

Responsibilities

• Contributes to supplier development quality program policies and forms.
• Reviews and approves supplier drawings and product quality plans.
• Develops supplier inspection procedures and first article requirements.
• Provides engineering guidance to Receiving Inspection including Gage R&R.
• Assesses supplier capabilities via visits, testing, and audits.
• Drives corrective actions and supplier performance reviews.

Skills

Leadership

Communication

Data analysis

Problem solving

Project management

Tools

SAP

Job description

Abbott in New Brighton, MN, seeks a Supplier Development Quality Engineer to lead supplier evaluation, qualification, and performance assessment. You will help develop and maintain supplier quality engineering methodologies, ensuring compliance with regulatory requirements.

You will guide purchasing, R&D, manufacturing and QA engineers, review supplier drawings and quality plans, and drive continuous improvement through data analysis, inspection procedures, and corrective actions.