Supplier Development Quality Engineer II - Pleasanton, ...

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.Leading an active lifestyle is important to the many people we serve. In Abbott''s Heart Failure division, we''re advancing the treatment of heart and vascular disease through breakthrough medical technologies in Electrophysiology & Heart Failure, allowing people to restore their health and get on with their lives. We are seeking an experienced, high caliber Engineer II Supplier Development Quality Engineer. Supplier Development Quality Engineers are responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. 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 guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements• Reviews and approves all supplied product drawings and component quality plans• Manages development of supplied product/component qualification plans, including supplier validations, control plans, 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• Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits• Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions• Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews• Contributes and participates in supplier performance reviews• Evaluates and develops Supplied Data Agreement, Skip Lot, Dock-to-Stock, CoC, and CoA partnerships with suppliers• Applies sound engineering analysis and judgement to reduce the need for inspection in accordance to program policies• Works with Manufacturing engineering to assess and address purchased product issues• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues• Design and conduct experiments for process optimization and/or improvement• Participate in or lead teams in supporting Supplier Development Quality program requirements (e.g., represent the Supplier Development Quality function as a Core Team Member)• Mitigates risk by working with the Suppliers to document Process Flow Charts, PFMEAs, and Control Plans• 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• Performs other related duties and responsibilities, on occasion, as assignedEDUCATION AND EXPERIENCE YOU''LL BRING Required • BS degree in Engineering or Technical Field or equivalent experience• 3-7 years Medical Device and/or Engineering experience• Ability to work in a highly matrixed and geographically diverse business environment• Ability to leverage and/or engage others to accomplish projects• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization• Multitasks, prioritizes and meets deadlines in timely manner• Strong organizational and follow-up skills, as well as attention to detailPreferred• Advanced degree preferred• Engineering experience and demonstrated use of Quality tools/methodologies• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971• Experience with PCBA and electronic components preferred• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner• Prior medical device experience preferred• ASQ CQE or other certifications preferredWHAT WE OFFER: At Abbott, you can have a good job that can grow into a great career. We offer: • Training and career development, with on-boarding programs for new employees and tuition assistance • Financial security through competitive compensation, incentives and retirement plans • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs • Paid time off • 401(k) retirement savings with a generous company match • The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully:"¯ Follow 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 and on Twitter @AbbottNews and @AbbottGlobal

Created: 2021-11-29