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Senior Supplier Development Quality Engineer - Pleasanton, CA

Company: St. Jude Medical, Cardiology Division, I
Location: pleasanton
Posted on: May 3, 2021

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. JOB DESCRIPTION: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 heart failure, allowing people to restore their health and get on with their lives.We are seeking an experienced, high caliber Senior Supplier Development Quality Engineer to be responsible to act as the site interface to suppliers.WHAT YOU'LL DODrives the development, maintenance and improvement of quality of components sourced from outside suppliers.Reviews new design specifications and proposes changes to existing specifications to support component quality and manufacturability.Develops all supplied component quality plans to drive component qualification throughout the lifecycle of the design.Manages development of supplied product inspection procedures and first article requirements.Provides engineering guidance to Abbott Receiving Inspection including statistical analysis, measurement techniques, and Gage R studies. Assesses supplier capabilities through direct visits, technical discussions, and directed testing. Collaborates with suppliers to develop comprehensive process validation strategies. Proactively communicates quality issues to suppliers as needed through supplier corrective action requests and technical discussions.Leads the investigation, resolution and prevention of supplied component nonconformances.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 thorough engineering analysis and judgement to reduce the need for inspection in accordance to program policies.Works with Manufacturing Engineering to assess and address supplied component issues. Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.Designs and conducts experiments for design and process optimization and/or improvement.Appropriately document experiment plans and results, including protocol writing and reports.Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)Participate in or lead teams in supporting Supplier Quality program requirements (e.g., represent the Supplier Quality function as a Core Team Member).Mitigates risk by work in partnership 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 assigned.EDUCATION AND EXPERIENCE YOU'LL BRINGRequiredBS degree in Engineering or Technical Field or equivalent experience; advanced degree preferredEngineering experience and demonstrated use of Quality tools/methodologiesDetailed knowledge of FDA, GMP, ISO 13485, and ISO 14971Solid communication and interpersonal skillsAdvanced computer skills, including statistical/data analysis and report writing skillsAbility to work in a highly matrixed and geographically diverse business environmentAbility to work within a team and as an individual contributor in a fast-paced, changing environmentAbility to leverage and/or engage others to accomplish projectsStrong verbal and written communications with ability to effectively communicate at multiple levels in the organizationMultitasks, prioritizes and meets deadlines in timely mannerStrong organizational and follow-up skills, as well as attention to detailAbility to travel approximately 10%Ability to maintain regular and predictable attendancePreferredProject management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner5+ years' experiencePrior medical device experience preferred but not necessary.Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)WHAT WE OFFERAt 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 priority Production areas that are clean, well-lit and temperature-controlled Training and career development, with onboarding 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 communitiesLearn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.comFollow 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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.JOB FAMILY:Engineering DIVISION:EPHF Electrophysiology & Heart Failure LOCATION:United States > Pleasanton : 6101 Stoneridge Dr ADDITIONAL LOCATIONS:WORK SHIFT:Standard TRAVEL:Yes, 10 % of the Time MEDICAL SURVEILLANCE:Not Applicable SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Keywords: St. Jude Medical, Cardiology Division, I, Pleasanton , Senior Supplier Development Quality Engineer - Pleasanton, CA, Other , pleasanton, California

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