Abbott · 11 hours ago
Supplier Quality Engineer I
Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Supplier Quality Engineer I role focuses on ensuring quality standards are maintained with suppliers, conducting assessments, and monitoring supplier performance to align with regulatory requirements.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
Responsibilities
Ensures that the Division Approved Supplier List is maintained and accurate
Assesses potential new suppliers and service providers for quality and quality system capabilities through the execution of on site or desk top audits, and review of other objective evidence, as required
Communicates Division approval requirements to supplier and monitors feedback per project timelines
Performs on-site quality assessments of new suppliers, as required, and ensures appropriate corrective action response to findings
Ensures Document Control is notified of any changes to supplier statuses, as they relate to the Agile Manufacturer’s Tab
Evaluates Exception Reports (ERs) issued for nonconforming supplied material and works with the supplier on the investigation and resolution of root cause issues
Notifies suppliers of customer complaints related to failures resulting from supplied material and requires investigation and corrective action
Monitors supplier performance and reports supplier quality trend data
Participates with Incoming Quality Control on the development of incoming inspection activities or the reduction of these activities through implementation and maintenance of the Material Certification Program
Responsible for approving First Article Inspections and/or Golden Samples, as initiated by suppliers
Assists with the evaluation and approval of supplier requested changes or improvements
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Qualification
Required
Bachelor's Degree in Engineering or Technical Field or equivalent experience or an equivalent combination of education and work experience
2 years' work-related experience
Quality Assurance experience in the medical device or pharmaceutical, or other quality managed industries
Working knowledge of applicable regulations, such as FDA QSR, ISO, MDD, &/or IVDD
Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
Solid communication and interpersonal skills
Preferred
Masters Degree Preferred
ASQ CQE or other certifications preferred
Benefits
Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
An excellent retirement savings plan with high employer contribution
Tuition reimbursement
Freedom 2 Save student debt program
FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Recent News
2025-12-31
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