● Responsible for reviewing/approving Design Control activities for on-market hardware and software products, including Abbott Diabetes Care (ADC) Readers, Meters, Sensors, and Digital Products● Ensure compliance as Quality lead for on-market development/change teams to support country product launches and other design changes● Responsible for reviewal and approval of Risk Management Reports, System Requirements, Verification and Validation activities, and Design Transfer activities● Serve as QA subject matter expert in Design Outputs Reviews● Support CAPA/Field Action related activities to enhance Design Control procedures/processes as a CAPA approver and CAPA subject matter expert● Support the release of product by reviewing batch records for clinical trials and product releases● Ability to work in a fast-paced environment on multiple high priority projects simultaneously, with accuracy, thoroughness, and attention to detail resulting in high quality deliverables● Provide support for internal and external audits conducted on ADC including FDA, BSI, External Partners● Mentor other QA Engineers in Design Control activities● Support a Design and Development project as Quality Assurance Representative

Served as subject matter expert (SME) or independent technical expert (ITE) for ADC product knowledge and investigation methods● Investigated and performed electrical troubleshooting on customer returned products to determine root cause of product failures● Provided individual direction and guidance to other Reliability Engineers to achieve team goals● Lead and/or participated in cross-functional team meetings to support organizational goals● Interacted with Quality Personnel by meeting regularly, responding to requests and explaining procedures to ensure alignment within the Quality System● Generated technical reports to document linkage or root cause of the product failure to symptoms reported by customers● Worked directly with the R&D Group to support and develop investigative troubleshooting methodologies for the Complaints Investigation Group (CIG) to utilize in root cause analysis● Translated engineering investigation methodologies into procedures which can be executed by CIG technicians and communicated information to operations production support engineers● Identified, developed, and implemented processes to improve department performance● Assisted in developing metrics to demonstrate the effectiveness of the complaint investigation process● Generated statistical reports on complaint data for tracking and trending purposes