Senior Specialist Quality Assurance (Supplier Quality)

Abbott • Des Plaines, IL

1d • Onsite

About The Position

This position works out of our Des Plaines, IL location in the Abbott Molecular, Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Senior Specialist Quality Assurance (Supplier Quality) will support in the selection, approval, and maintenance of the division's approved suppliers by performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and/or improvement activities.

Requirements

• Bachelors or an equivalent combination of education and work experience.
• 6 Quality Assurance experience in the medical device, pharmaceutical or other quality managed industries.
• Demonstrated writing and communication skills are required for this position.
• Must be able to explain audit results and influence other's understandings of audit observations in a tactful and professional manner.
• A thorough understanding of the ISO/QMSRs and the ability to apply that knowledge with an understanding of business operations to achieve regulatory compliance is needed.

Nice To Haves

• Working knowledge of applicable regulations such as FDA, QSR, ISO, MDD, or IVDD.
• Knowledge in the areas of design controls, verification and validation activities, manufacturing practices, and statistical techniques.
• Experience in conducting external quality assessments.
• Certified Lead Auditor trained.

Responsibilities

• 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.
• Performs on-site quality assessments of new suppliers, as required, and ensures appropriate corrective action response to findings.
• Ensures that the division’s approved supplier list is maintained and accurate.
• Leads in the evaluation and approval of supplier requested changes or improvements.
• Evaluates Exception Reports (SCARs) 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 require investigation and corrective action.
• Monitors supplier performance and reports supplier quality trend data.
• Drives improvement projects, as required, to improve supplier performance.
• Assists in the preparation of area metric data for delivery to Sr. Management.
• Recommend areas for supplier improvement, as appropriate.
• Work cross functionally within MDx with R&D, Design Quality, Manufacturing, Purchasing and IQA when qualifying and monitoring supplier performance.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees