Abbott Supplier QA Engineer II in Abbott Park, Illinois

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Summary:

This Supplier Quality Assurance Engineer II position is focused on supporting a new manufacturing line in the Chicago area for our FreeStyle Libre product (recently PMA approved). The ideal candidate has experience in injection molding, components, process engineering, process validation, automation and supplier quality engineering within the medical device industry, in a high volume environment.

Main Responsibilities:

Supports 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. Ensures manufacturing processes are validated as applicable and products meet quality requirements.

  • Communicates division’s approval requirements to supplier and monitors feedback per project timelines.

  • Ensures that the supplier performs and documents the appropriate engineering approach to activities such as qualification and validation and provides assistance in these efforts, as appropriate.

  • Leads in the evaluation and approval of supplier requested changes or improvements. This activity may also include the identification and/or approval of a new supplier to provide an alternate material, or changes in parts or processes used at the supplier/TPM.

  • Evaluates Exception Reports (ERs) issued for nonconforming supplied material and works with the supplier on the investigation and resolution of root cause issues.

  • Monitors supplier performance and reports supplier quality trend data. Drives improvement projects, as required, to improve supplier performance.

  • Performs on-site quality assessments of new suppliers, as required

  • Conducts site visits at supplier sites to bring back understanding on how to resolve quality issues (process audits).

  • Ensures appropriate corrective action response to findings.

  • Notifies suppliers of customer complaints related to failures resulting from supplied material and requires investigation and corrective action.

  • Assists in the preparation of area metric data for delivery to Sr. Management. Recommends areas for supplier improvement, as appropriate.

  • 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.

  • Ensures that the division’s 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.

  • Ensures Document Control is notified of any changes to supplier statuses, as they relate to the Agile Manufacturer’s Tab.

Qualifications:

Minimum 6 years of Quality Assurance experience in the medical device, pharmaceutical or other quality managed industries. Working knowledge of applicable regulations such as FDA, QSR, ISO, MDD, or IVDD. Knowledge in the areas of design controls, process validation, manufacturing practices and statistical techniques. Experience in conducting external quality assessments. Certified Lead Auditor trained.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com