Senior Supplier Quality Engineer — Medical Devices

Thornton Tomasetti; Saint Paul (MN); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott is seeking a Supplier Development Quality Engineer for the Structural Heart division in Minnesota. The role focuses on supplier selection, qualification, and quality assurance, ensuring regulatory compliance and robust supplier performance.

Ideal candidates have 5+ years in medical device quality, strong leadership, and experience with SAP and Six Sigma. The role requires on-site work in New Brighton, MN with occasional travel.

Qualifications

• Minimum 5 years of related experience in supply chain, planning, or operations with medical device context.
• Strong knowledge of FDA regulations, GMP, ISO 13485, and ISO 14971.
• Experience with SAP and maintaining master data integrity.
• Proven project management and leadership capabilities.
• Advanced data analysis and report-writing skills.

Responsibilities

• Develop and maintain supplier quality program policies, procedures, and forms.
• Coach and mentor technical teams in applying program requirements.
• Provide guidance to Purchasing, R&D, Manufacturing, and Quality engineers.
• Review and approve supplier drawings and quality plans.
• Develop inspection procedures and first article requirements.
• Provide engineering guidance to Receiving Inspection including Gage R&R studies.
• Assess supplier capabilities through visits and audits.
• Communicate quality issues to suppliers and track corrective actions.
• Lead supplier performance reviews and data partnerships.
• Apply systematic problem-solving to reduce inspection needs.

Skills

Quality engineering

FDA regulations

GMP

ISO 13485

ISO 14971

Six Sigma

Lean Manufacturing

Data analysis

Project management

Leadership

Education

Engineering degree

Tools

SAP

Quality systems tooling

Job description

Abbott is seeking a Supplier Development Quality Engineer for the Structural Heart division in Minnesota. The role focuses on supplier selection, qualification, and quality assurance, ensuring regulatory compliance and robust supplier performance.

Ideal candidates have 5+ years in medical device quality, strong leadership, and experience with SAP and Six Sigma. The role requires on-site work in New Brighton, MN with occasional travel.