Sr. Supplier Quality Engineer

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 is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our New Brighton, MN location on our Structural Heart team.

Supplier Development Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection.Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements.

What You’ll Work On

• 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.

Required Qualifications

• Bachelor’s degree in Engineering, Manufacturing Engineering, Biomedical Engineering, or a 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.

Preferred Qualifications

• Medical device industry experience.
• ISO 13485 auditor certification or significant auditing experience, including both 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/material validation activities.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

The base pay for this position is

$78,000.00 – $156,000.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

SH Structural Heart

LOCATION:

United States > Minnesota > St. Paul : 1225 Old Highway 8 NW

WORK SHIFT:

Standard

TRAVEL:

Yes, 25 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf