Senior Supplier Quality Engineer – Medical Devices

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

Job summary

Abbott’s Structural Heart team in New Brighton, MN, is seeking a Supplier Development Quality Engineer to lead supplier qualification, evaluate performance, and support CAPA activities. You will help establish quality systems, review drawings, and guide inspection plans across Purchasing, Manufacturing, and R&D.

Travel up to 25% required. Qualified candidates hold a bachelor’s degree in engineering and 5+ years in supplier quality roles, with strong writing skills and experience with CAPA,

Qualifications

• Bachelor’s degree in Engineering, Manufacturing Engineering, Biomedical Engineering, or related technical discipline.
• 5+ years of experience in Supplier Quality Engineering, Supplier Development, Manufacturing Quality, or a related quality function.
• Strong knowledge of FDA Quality System Regulations, GMP, and ISO 13485 requirements.
• Experience conducting supplier audits, supplier qualification activities, and supplier performance evaluations.
• Experience managing CAPA activities, supplier corrective actions, nonconforming materials, and root cause investigations.
• Strong technical writing skills, including audit reports, supplier quality agreements, procedures, and corrective action documentation.
• Experience with quality engineering tools and methodologies such as FMEA, CAPA, Statistical Analysis, Root Cause Analysis, and Gage R&R.
• Proficiency with SAP or similar ERP systems and experience using data analysis/reporting tools such as Power BI.
• Strong communication, collaboration, and project management skills.
• Ability to travel up to 25%, including occasional international travel.

Responsibilities

• Support supplier selection, evaluation, qualification, and ongoing performance management activities.
• Contribute to the development, implementation, and continuous improvement of Supplier Development Quality policies, procedures, methodologies, and systems.
• Provide quality engineering support to Purchasing, Manufacturing, R&D, Receiving Inspection, and Operations teams.
• Review and approve supplied product drawings, specifications, and component quality plans.
• Develop and maintain supplied product inspection plans, receiving inspection requirements, and first article inspection processes.
• Provide engineering guidance related to statistical analysis, measurement techniques, Gage R&R studies, sampling plans, and inspection methods.
• Assess supplier capabilities through supplier audits, technical reviews, on-site visits, and quality system evaluations.
• Lead and support supplier quality audits, including both internal and external supplier assessments.
• Drive supplier corrective actions and follow-up activities to ensure root cause identification and sustainable corrective action implementation.
• Manage supplier-related nonconforming material investigations and participate in Material Review Board (MRB) activities.
• Support CAPA activities, supplier exceptions, and implementation of quality system improvements.
• Monitor supplier performance through scorecards, KPI tracking, and supplier performance reviews.
• Develop and maintain supplier quality agreements and supplied data agreements.
• Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve supplier quality issues.
• Partner with manufacturing and quality teams to address supplier-related production issues and drive process improvements.
• Design and conduct experiments to support process optimization and continuous improvement initiatives.
• Participate on cross-functional project teams as the Supplier Quality representative.
• Prepare technical documentation including audit reports, supplier agreements, quality procedures, nonconformance reports, and corrective action documentation.
• Develop reports and dashboards to support supplier performance monitoring and executive reporting.
• Ensure compliance with FDA regulations, ISO standards, and internal quality system requirements.
• Build strong partnerships with suppliers and cross-functional stakeholders to drive continuous improvement and operational excellence.
• Travel domestically and internationally as needed to support supplier management activities.

Skills

Quality regulations knowledge

CAPA processes

Root cause analysis

Technical writing

Project management

Education

Bachelor’s degree in Engineering/related field

Tools

SAP

Power BI

Windchill

CatsWeb

Job description

Abbott’s Structural Heart team in New Brighton, MN, is seeking a Supplier Development Quality Engineer to lead supplier qualification, evaluate performance, and support CAPA activities. You will help establish quality systems, review drawings, and guide inspection plans across Purchasing, Manufacturing, and R&D.

Travel up to 25% required. Qualified candidates hold a bachelor’s degree in engineering and 5+ years in supplier quality roles, with strong writing skills and experience with CAPA,