Senior Supplier Quality Engineer | MedTech Quality Leader

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

Benefits offered by this job

Health benefits

Retirement plan

Job summary

Abbott’s Structural Heart team in New Brighton, MN seeks a Supplier Development Quality Engineer to oversee supplier quality engineering, audits, CAPA, and performance management. This role ensures FDA/ISO compliance and drives continuous improvement with cross-functional teams.

The position requires a bachelor’s in engineering and 5+ years in supplier quality or related fields, with 25% travel (domestic/international). Proficiency in SAP and Power BI is preferred.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• 5+ years in Supplier Quality/Manufacturing Quality or related quality function.
• Strong knowledge of FDA QSR, GMP, ISO 13485.
• Experience with supplier audits, qualification and evaluations.
• Experience managing CAPA, nonconforming materials, and root cause investigations.
• Strong technical writing for audit reports and supplier quality docs.
• Familiarity with quality tools like FMEA, CAPA, statistics, Gage R&R.
• SAP or similar ERP and data-analytics tools (Power BI).
• Willingness to travel up to 25%, including international travel.

Responsibilities

• Support supplier selection, evaluation, qualification, and performance management.
• Develop and improve Supplier Development Quality policies and systems.
• Provide engineering support to Purchasing, Manufacturing, R&D, Receiving, and Operations.
• Review and approve drawings, specs, and quality plans.
• Develop inspection plans and first article inspection processes.
• Guide statistical analysis, measurement methods, and Gage R&R.
• Assess supplier capabilities via audits, reviews, and on-site visits.
• Lead supplier quality audits and corrective actions.
• Monitor supplier performance with scorecards and KPIs.
• Create supplier quality agreements and data sharing docs.

Skills

Quality engineering

Regulatory knowledge

Project management

Cross-functional teamwork

Education

Bachelor's in Engineering

Tools

SAP

Power BI

Job description

Abbott’s Structural Heart team in New Brighton, MN seeks a Supplier Development Quality Engineer to oversee supplier quality engineering, audits, CAPA, and performance management. This role ensures FDA/ISO compliance and drives continuous improvement with cross-functional teams.

The position requires a bachelor’s in engineering and 5+ years in supplier quality or related fields, with 25% travel (domestic/international). Proficiency in SAP and Power BI is preferred.