Senior Supplier Development Quality Engineer

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. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors 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. Leading an active lifestyle is important to the many people we serve. In Abbotts Heart Failure division, were 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 Youll Work On Drives 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&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. Required Qualifications BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred Engineering experience and demonstrated use of Quality tools/methodologies Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 Solid communication and interpersonal skills Advanced computer skills, including statistical/data analysis and report writing skills Ability to work in a highly matrixed and geographically diverse business environment Ability to work within a team and as an individual contributor in a fast-paced, changing 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 detail Ability to travel approximately 10% Ability to maintain regular and predictable attendance Preferred Qualifications 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 5+ years experience Prior medical device experience preferred but not necessary. Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing) Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow 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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews. The base pay for this position is $86,700.00 $173,300.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: HF Heart Failure LOCATION: United States > Pleasanton : 6101 Stoneridge Dr ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day) 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 Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether its next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lifes greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter