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.

Senior Supplier Quality Engineer

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. You’ll 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 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 Opportunity

This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

As a Senior Supplier Quality Engineer, you'll have the chance to be part of a team of Engineers responsible for activities related to supplier selection, evaluation, re-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 Work On

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)Participate in or lead teams supporting new product development associated to supplier development and managementProvides engineering guidance to Abbott Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies, and inspection proceduresMitigates risk by working with the Suppliers to document Process Flow Charts, PFMEAs, and Control PlansApply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issuesEvaluates and develops Supplied Data Agreement, Skip Lot, Dock-to-Stock, CoC, and CoA partnerships with suppliersReviews and approves all supplied product drawings and component quality plansProvides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirementsPerforms audits and re-assessment of suppliers each year per a defined scheduleIdentifies supplier contacts and solicits required documents from suppliersTracks supplier responses and conducts follow-up and escalation as necessaryConduct phone calls with supplier as needed to expedite responses or answer questionsReviews current Quality Agreements and determines need to reviseSolicits revised Quality Agreements as determinedObtains and analyzes performance and quality indications information from internal sources for each supplierPrepares and submits required quality records and documents for closure and filing.Manages the development of supplied product inspection procedures and first article requirementsAssesses supplier capabilities through direct visits, technical discussions directed testing and quality system auditsProactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests, and technical discussionsParticipates and provides engineering ownership for all supplied product Non-Conforming Material ReviewsContributes and participates in supplier performance reviewsApplies sound engineering analysis and judgment to reduce the need for inspection in accordance with program policiesWorks with Manufacturing engineering to assess and address purchased product issuesDesign and conduct experiments for process optimization and/or improvementComplies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignmentsContributes to the development, maintenance, and improvement of Abbott supplier development quality program policies, procedures, and forms

Required Qualifications

BS degree in Engineering or Technical Field or equivalent experience5 + years of Engineering experience in a regulated industryAbility to work in a highly matrixed and geographically diverse business environmentStrong verbal and written communications with ability to effectively communicate at multiple levels in the organizationAbility to leverage and/or engage others to accomplish projectsStrong technical writing skillsExperience with root cause identification and problem solving

Preferred Qualifications

Advanced degree preferredMedical device industry experience preferredEngineering experience and demonstrated use of Quality tools/methodologiesDetailed knowledge of FDA, GMP, ISO 13485, and ISO 14971Strong 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 mannerPrior medical device experienceASQ CQE or other certifications

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 and @AbbottGlobal

The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.