Sr. Supplier Quality Engineer

Abbott • Lake Forest, IL

22h • $78,000 - $156,000

About The Position

Abbott is seeking a Senior Supplier Quality Engineer (SQE) to lead and support supplier quality activities across the product and service lifecycle. This role is responsible for ensuring that suppliers consistently meet Abbott’s quality, regulatory, and business requirements. The Senior SQE will act as a key technical and quality liaison between Abbott and its suppliers, driving continuous improvement, risk mitigation, and compliance with global regulations. This role also supports general QMS processes where applicable, including quality investigations

Requirements

• Bachelor’s degree in Engineering, Quality, or a related technical field
• 6+ years of experience in Supplier Quality, Quality Engineering, or Manufacturing Quality in a regulated industry
• Strong knowledge of FDA QSR, ISO 13485, GMP, and global regulatory requirements
• Proven experience conducting supplier audits and managing CAPAs
• Demonstrated ability to analyze data, assess risk, and make sound quality decisions

Nice To Haves

• Experience in toxicology testing, medical devices, diagnostics, pharmaceuticals, or combination products
• ASQ certification (CQE, CQA) or equivalent preferred
• Experience with PPAP, APQP, FMEA, SPC, and process validation
• Strong project management and cross‑functional leadership skills
• Ability to travel domestically and internationally (up to ~25%)

Responsibilities

• Lead supplier qualification, selection, and onboarding activities, including supplier risk assessments and quality agreements
• Develop and maintain supplier quality plans aligned with Abbott and regulatory requirements
• Serve as the primary quality contact for assigned suppliers
• Plan, conduct, and lead supplier audits (onsite and remote) to applicable standards (e.g., ISO 13485, FDA QSR, GMP)
• Evaluate audit findings, ensure timely and effective corrective actions, and verify closure
• Support internal, regulatory, and notified body inspections related to supplier quality
• Lead investigations of supplier nonconformances, deviations, and escapes
• Ensure robust root cause analysis and effective corrective and preventive actions (CAPA)
• Monitor supplier performance metrics and trends to proactively address risks
• Review and approve supplier‑initiated changes impacting product, process, or materials
• Assess regulatory and quality impact of changes and ensure proper implementation
• Collaborate with cross‑functional teams to ensure controlled and compliant changes
• Drive supplier quality improvement initiatives to enhance capability, reliability, and cost efficiency
• Mentor junior SQEs and contribute to the development of supplier quality best practices
• Support new product introductions (NPI) by ensuring supplier readiness and process validation

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical 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.

What This Job Offers

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