Sr. Supplier Quality Engineer

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 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

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

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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

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.