Design Control Engineer

Follow your aspirations to Abbott for diverse opportunities, competitive salaries, great benefits, a 401(k) retirement savings plan, a company paid pension plan and profit sharing, all with a company providing the growth and strength to build your future.Lead and/or support Design Control activities for new product, on-market products or process development, including design and development planning, design reviews, design input/output, design verification/validation, design history files, design transfer, risk management, etc. Ensure that all new and/or modified design control documents are in full alignment with Quality System requirements. Provide support to maintain Quality System Regulation requirements including internal and external audits of Quality Sub-Systems.Recommend improvements and implement changes to site design control processes and procedures by assessing FDA regulations, design control practice in industry and other Abbott divisions.Support organizational company goals and objectives, policies and procedures in product complaint process, CAPA system, change control, etcQualificationsIn-depth understanding of design control, verification and validation principles, FDA 21 CFR 820.30, ISO 13485 (2003) and risk analysis per ISO 14971 (2007)D5-10 years experience of product development within medical device industry emonstrated process improvement experience in an FDA/cGMP regulated environment Bachelor degree required,Scientficor Engineering preferredAbbott welcomes and encourages diversity in our workforce. EEO/AATo apply for this position, click here.To learn more about Abbott and view other opportunities, click here.