Abbott
Senior Supplier Development Quality Engineer
Abbott, Minneapolis, Minnesota, United States, 55447
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 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
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 requirements
Performs re-assessment of suppliers each year per a defined schedule
Identifies supplier contacts and solicits required documents from suppliers
Tracks supplier responses and conducts follow-up and escalation as necessary
Conduct phone calls with supplier as needed to expedite responses or answer questions
Reviews current Quality Agreements and determines need to revise
Solicits revised Quality Agreements as determined
Obtains and analyzes performance and quality indications information from internal sources for each supplier
Prepares and submits required quality records and documents for closure and filing
Reviews and approves all supplied product drawings and component quality plans
Manages the development of supplied product 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 judgment to reduce the need for inspection in accordance with program policies
Works with Manufacturing engineering to assess and address purchased product issues
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
Contributes to the development, maintenance, and improvement of Abbott supplier development quality program policies, procedures, and forms
Required QualificationsBS degree in Engineering or Technical Field or equivalent experience
5+ years Medical Device and/or Engineering experience
3+ years Supplier Development Engineering experience
Strong technical writing skills
Experience with root cause identification and problem solving
Preferred QualificationsAdvanced degree
Medical device experience
Engineering experience and demonstrated use of Quality tools/methodologies
Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
Experience 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 manner
ASQ CQE or other certifications
Apply Now* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:
www.abbottbenefits.comFollow 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 X @AbbottNews.The base pay for this position is$72,700.00 – $145,300.00
In specific locations, the pay range may vary from the range posted.JOB FAMILY:
Operations Quality
DIVISION:
EP Electrophysiology
LOCATION:
United States > Minnesota > Plymouth : 5050 Nathan Lane N
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
No
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), Continuous walking for prolonged periods (more than 2 hours at a time 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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf#J-18808-Ljbffr
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
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 requirements
Performs re-assessment of suppliers each year per a defined schedule
Identifies supplier contacts and solicits required documents from suppliers
Tracks supplier responses and conducts follow-up and escalation as necessary
Conduct phone calls with supplier as needed to expedite responses or answer questions
Reviews current Quality Agreements and determines need to revise
Solicits revised Quality Agreements as determined
Obtains and analyzes performance and quality indications information from internal sources for each supplier
Prepares and submits required quality records and documents for closure and filing
Reviews and approves all supplied product drawings and component quality plans
Manages the development of supplied product 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 judgment to reduce the need for inspection in accordance with program policies
Works with Manufacturing engineering to assess and address purchased product issues
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
Contributes to the development, maintenance, and improvement of Abbott supplier development quality program policies, procedures, and forms
Required QualificationsBS degree in Engineering or Technical Field or equivalent experience
5+ years Medical Device and/or Engineering experience
3+ years Supplier Development Engineering experience
Strong technical writing skills
Experience with root cause identification and problem solving
Preferred QualificationsAdvanced degree
Medical device experience
Engineering experience and demonstrated use of Quality tools/methodologies
Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
Experience 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 manner
ASQ CQE or other certifications
Apply Now* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:
www.abbottbenefits.comFollow 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 X @AbbottNews.The base pay for this position is$72,700.00 – $145,300.00
In specific locations, the pay range may vary from the range posted.JOB FAMILY:
Operations Quality
DIVISION:
EP Electrophysiology
LOCATION:
United States > Minnesota > Plymouth : 5050 Nathan Lane N
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
No
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), Continuous walking for prolonged periods (more than 2 hours at a time 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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf#J-18808-Ljbffr