Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:Career development with an international company where you can grow the career you dream of.Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent retirement savings plan with high employer contributionTuition reimbursement, the Freedom 2 Save ( student debt program and FreeU ( education benefit - an affordable and convenient path to getting a bachelor’s degree.A company recognized as a great place to work in dozens of countries around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.The OpportunityThis position works out of our Santa Clara, CA location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.What You’ll Work OnManages & monitor site NCR/CAPA including reporting requirements, provide detailed updates and information in support of quality, also liaising with other Abbott sites to ensure compliance to quality system.Perform or review manufacturing non-conformances reports, CAPA, failure investigations and audit findings to report manufacturing related issues that may impact quality and recommend courses of corrective action.Prepare metrics for NCRs, CAPA, suppliers’ performance and analyze process data and trends and drives optimization and improvement. Perform and report line defects trend analysis.Interface with suppliers to ensure product meets specifications.Audit the work of others through review of labeling, documentation (MPI’s, LHR’s, etc.) and lot history records and provide final quality approval.Work within a GMP environment and document results per GDP standards. Holds R&D, and operations accountable to GMP and GDP requirements.Support sterilization activities and documentation (submission forms, LAL, Bioburden, etc.)Ensure training requirements for internal and external staff are established and maintained in a training matrix.Conduct and assign training initially for new staff and follow up on training due to changes or re-review.Leads cross-functional teams to achieve consensus for deliverables associated with quality issues.Maintain inspection procedures for the inspection of incoming materials, in-process materials and finished goods. Select appropriate inspection, test and measurement equipment, fixtures, and gauges.Ensure compliance with all procedures and all applicable regulatory agency requirements.Identifies continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization.Work with engineers and manufacturing to transfer technical information into easy to understand written form, as well as take a hands-on approach to learning and documenting the processes.Other duties as assigned.Required QualificationsBachelor’s degree in Engineering or equivalent or a related field.6 years (+) experience in Quality Assurance/Quality Engineering from medical device or pharmaceutical industry.Regulations experience in any: 820, FDA, 13485, 14971.Proven experience in relevant areas of Quality, Regulatory or Engineering, preferably within a medical device environmentAdvanced knowledge of relevant regulations is required to act as a resource for colleagues.Must be able to take accountability with excellent follow up and follow through.Strong written and verbal communication skills and ability to collaborate effectively.Capable of producing results working unsupervised under own initiative.Must be an effective team player with the ability to mentor, lead and problem solve to provide solutions to the business.Confident and open personality who is able to communicate effectively, both written and orally with people at all levels.Experience with external/internal audits and EtO Sterilization a plus.Ability to work efficiently under tight timelines.Apply Now ( who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.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.Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION.The base pay for this position is $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.An Equal Opportunity EmployerAbbot 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