Abbott Laboratories
Senior Supplier Development Quality Engineer
Abbott Laboratories, Minneapolis, Minnesota, United States, 55447
Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent retirement savings plan with a high employer contributionTuition reimbursement, the
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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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.The OpportunityThis position works out of our Plymouth, MN location in the EP 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 the Senior Supplier Development Quality Engineer, you'll have the chance to provide expertise in 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 OnProvides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirementsPerforms 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 necessaryConducts phone calls with suppliers 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 filingReviews and approves all supplied product drawings and component quality plansManages the development of supplied product inspection procedures and first article requirementsProvides engineering guidance to Abbott Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies, and inspection proceduresAssesses 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 reviewsEvaluates and develops Supplied Data Agreement, Skip Lot, Dock-to-Stock, CoC, and CoA partnerships with suppliersApplies 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 issuesParticipates in or leads 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 PlansComplies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignmentsMaintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendorsContributes to the development, maintenance, and improvement of Abbott supplier development quality program policies, procedures, and formsRequired QualificationsBS degree in Engineering or Technical Field or equivalent experience5+ years Medical Device and/or Engineering experience3+ years Supplier Development Engineering experienceStrong technical writing skillsExperience with root cause identification and problem solvingPreferred QualificationsAdvanced degreeMedical device experienceEngineering experience and demonstrated use of Quality tools/methodologiesDetailed knowledge of FDA, GMP, ISO 13485, and ISO 14971Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing). ASQ CQE or other certifications are 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 mannerASQ CQE or other certificationsApply Now
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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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.The OpportunityThis position works out of our Plymouth, MN location in the EP 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 the Senior Supplier Development Quality Engineer, you'll have the chance to provide expertise in 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 OnProvides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirementsPerforms 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 necessaryConducts phone calls with suppliers 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 filingReviews and approves all supplied product drawings and component quality plansManages the development of supplied product inspection procedures and first article requirementsProvides engineering guidance to Abbott Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies, and inspection proceduresAssesses 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 reviewsEvaluates and develops Supplied Data Agreement, Skip Lot, Dock-to-Stock, CoC, and CoA partnerships with suppliersApplies 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 issuesParticipates in or leads 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 PlansComplies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignmentsMaintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendorsContributes to the development, maintenance, and improvement of Abbott supplier development quality program policies, procedures, and formsRequired QualificationsBS degree in Engineering or Technical Field or equivalent experience5+ years Medical Device and/or Engineering experience3+ years Supplier Development Engineering experienceStrong technical writing skillsExperience with root cause identification and problem solvingPreferred QualificationsAdvanced degreeMedical device experienceEngineering experience and demonstrated use of Quality tools/methodologiesDetailed knowledge of FDA, GMP, ISO 13485, and ISO 14971Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing). ASQ CQE or other certifications are 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 mannerASQ CQE or other certificationsApply Now
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