Senior Specialist Quality Assurance (Supplier Quality)

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. Youll also have access to:

• 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 bachelors 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 Des Plaines IL location in the Abbott Molecular Diagnostics Division. Were 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 Abbotts 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 divisions approved suppliers by performing supplier quality system assessments monitoring supplier performance and driving supplier corrective action and/or improvement activities.

What Youll Work On

• 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 divisions 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.

• Demonstrated writing and communication skills are required for this position.

• Must be able to explain audit results and influence others 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.

Required Qualifications

• Bachelors or an equivalent combination of education and work experience.

• 6 Quality Assurance experience in the medical device pharmaceutical or other quality managed industries.

Preferred Qualifications

• 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.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives: your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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