Sr. Supplier Quality Engineer

Abbott • New Brighton, MN

8d • $78,000 - $156,000

About The Position

This position works on Abbott’s Structural Heart team at its New Brighton, Minnesota location. The Supplier Development Quality Engineer is responsible for supplier selection and evaluation, material qualification, supplier performance, and receiving inspection. The role contributes to supplier quality engineering methodologies, systems, and practices that meet company and regulatory requirements. It provides quality engineering support across Purchasing, Manufacturing, R&D, Receiving Inspection, and Operations, and collaborates with suppliers and cross-functional stakeholders to resolve quality issues and improve processes. Domestic and international travel may be required, up to 25% of the time.

Requirements

• Bachelor’s degree in Engineering, Manufacturing Engineering, Biomedical Engineering, or a related technical discipline.
• At least 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 or reporting tools such as Power BI.
• Strong communication, collaboration, and project management skills.
• Ability to travel up to 25%, including occasional international travel.

Nice To Haves

• Medical device industry experience.
• ISO 13485 auditor certification or significant auditing experience, including internal and supplier audits.
• Experience with Windchill, CatsWeb, or similar quality management systems.
• ASQ Certified Quality Engineer (CQE), Six Sigma, Lean Manufacturing, or related certification.
• Experience supporting New Product Development (NPD), supplier qualification, and component or material validation activities.

Responsibilities

• Support supplier selection, evaluation, qualification, and ongoing performance management.
• 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 on 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 internal and external supplier quality audits and assessments.
• Drive supplier corrective actions and follow-up to ensure root cause identification and sustainable corrective action implementation.
• Manage supplier-related nonconforming material investigations and participate in Material Review Board activities.
• Support CAPA activities, supplier exceptions, and quality system improvements.
• Monitor supplier performance using scorecards, KPIs, 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.
• 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 for supplier performance monitoring and executive reporting.
• Ensure compliance with FDA regulations, ISO standards, and internal quality system requirements.
• Build 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.

Benefits

• Career development with an international company.
• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, offering an affordable and convenient path to earning a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior