Sr. Supplier Quality Engineer jobs in United States
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Abbott · 1 day ago

Sr. Supplier Quality Engineer

Abbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking a Senior Supplier Quality Engineer to lead and support supplier quality activities across the product and service lifecycle, ensuring suppliers meet quality and regulatory requirements.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

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

Qualification

Supplier Quality EngineeringFDA QSRISO 13485CAPA ManagementData AnalysisRisk AssessmentProject ManagementSupplier AuditsRoot Cause AnalysisProcess ValidationToxicology TestingASQ CertificationFMEASPCAPQPCross-functional Leadership

Required

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

Preferred

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%)

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.

Company

Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.

Funding

Current Stage
Public Company
Total Funding
$6.79M
2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO

Leadership Team

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Robert Ford
President & Chief Executive Officer
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Mike Peterson
Senior Vice President
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Company data provided by crunchbase