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Supplier Quality Engineer II

Company: Abbott Laboratories
Location: Saint Paul
Posted on: January 15, 2022

Job Description:

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 109,000 colleagues serve people in more than 160 countries.Supplier Quality Engineer II (Woodridge location) 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.-- - We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care. We are currently hiring for a Supplier Quality Engineer II role based in our St Paul location. In this role you will be responsible for activities focused on receiving inspection, fixture creation, tool qualification, method development, material qualification, and associated validation activities. This position contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet Abbott and regulatory requirements. WHAT YOU'LL DO-- - -Contributes to the development, maintenance and improvement of Abbott supplier development quality program policies, procedures and forms-- - -Provides Supplier quality focused Quality System Body of Knowledge support to Division and organization-- - -Ensures compliance to ISO 13485, 21CFR 820, MDR Quality System Regulations, and other applicable regulations and standards by providing support for interpretation of regulations, performing gap analysis, and leading activities to implement improvements.-- - -Tracks supplier responses and conducts follow-up and escalation as necessary-- - -Reviews and approves supplied material drawings and component quality plans-- - -Manages development of supplied material receiving inspection procedures and first article requirements-- - -Provides engineering guidance to Abbott Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures-- - -Assess supplier process capabilities, develop supplied component sampling plans, and support vendor qualifications and validations-- - -Complete Document Change Request Reviews in a timely and objective manner-- - -Provide supplier quality support for new product development teams-- - -Manage Supplier Corrective Action Requests (SCARs), Supplier Change Notifications (SCNs/SCRs) and Nonconforming Material reports (NCMRs)-- - -Additional duties may be identified by functional management based on the current project/business objectives.-- - -Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. EDUCATION AND EXPERIENCERequired-- - -BS Degree in Engineering or Technical Field or an equivalent combination of education and work experience-- - -2+ years Medical Device and/or Engineering experience-- - -Ability to work in a highly matrixed and geographically diverse business environment.-- - -Ability to work within a team and as an individual contributor-- - -Ability to leverage and/or engage others to accomplish projectsWHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer:A fast-paced work environment where your safety is our priorityProduction areas that are clean, well-lit and temperature-controlled Training and career development, with onboarding programs for new employees and tuition assistanceFinancial security through competitive compensation, incentives and retirement plansHealth care and well-being programs including medical, dental, vision, wellness and occupational health programsPaid time off401(k) retirement savings with a generous company matchThe stability of a company with a record of strong financial performance and history of being actively involved in local communitiesLearn more about our benefits that add real value to your life to help you live fully:-- - your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at , on Facebook at /Abbott and on Twitter @AbbottNews and @AbbottGlobal.

Keywords: Abbott Laboratories, St. Paul , Supplier Quality Engineer II, Engineering , Saint Paul, Minnesota

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