Senior Specialist Quality Assurance

at ABBOTT LABORATORIES in Buffalo Grove, Illinois, United States

Job Description

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 utilizing experience in medical device, pharmaceutical, or other quality regulated environment. Work within an Agile methodology environment. Communicate division’s approval requirements to supplier and monitor feedback per project timelines. Apply and ensure manufacturing compliance with regulations such as FDA 21 CFR 820 Quality Systems Regulations (QSR), ISO 13485, Medical Device Directives (MDD) and In-Vitro Diagnostic Directives (IVDD). Support Corrective Action/Preventative Action (CAPA) process and root cause investigations. Use design controls, verification and validation activities, manufacturing practices, and statistical techniques including JMP and/or Minitab. Conduct external or internal quality assessments. Develop and execute qualifications and process validations, including Installation Qualification (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Perform on-site quality assessments of new suppliers and ensure appropriate corrective action response to findings. Ensure Document Control is notified of any changes to supplier status as they relate to the Agile Manufacturer’s Tab. Lead evaluation and approval of supplier requested changes or improvements, including identification and/or approval of a new supplier to provide an alternate material. Conduct site visits at supplier sites to bring back understanding on resolving quality issues and process audits. Evaluate Exception Reports (ERs) issued for nonconforming supplied material and work with the supplier on investigation and resolution of root cause issues. Notify suppliers of customer complaints related to failures resulting from supplied material which requires investigation and corrective action. Monitor supplier performance and report on supplier quality trend data.  Drive improvement projects as required to improve supplier performance. Assist in the preparation of area metric data for delivery to senior management.