Abbott
Supplier Quality Engineer II
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 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) PPO.An excellent retirement savings plan with high employer contribution.Tuition reimbursement and other educational benefits.A company recognized as a great place to work in dozens of countries.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.The OpportunityThis position works out of our Plymouth, MN location in the Electrophysiology division. As the Supplier Quality Engineer II, you’ll be responsible for activities related to new product development, supplier selection, 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 OnCore team supplier quality lead for EP new product development projects.Provides guidance and training to Purchasing, R&D, Manufacturing, and Quality engineers in applying program requirements.Identifies supplier contacts and solicits required documents from suppliers.Tracks supplier responses and conducts follow-up and escalation as necessary.Conduct phone calls with suppliers 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 and inspection procedures.Assesses supplier capabilities through direct visits and quality system audits.Proactively communicates quality issues to suppliers as needed.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.Works with Manufacturing engineering to assess and address purchased product issues.Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.Design and conduct experiments for process optimization and/or improvement.Participate in or lead teams in supporting Supplier Development Quality program requirements.Mitigates risk by working with suppliers to document Process Flow Charts, PFMEAs, and Control Plans.Complies with U.S. Food and Drug Administration (FDA) regulations and company policies.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.Performs other related duties and responsibilities, on occasion, as assigned.Required QualificationsBS degree in Engineering or Technical Field or equivalent experience.2-5 years Medical Device and/or Engineering experience.Ability to work in a highly matrixed and geographically diverse business environment.Strong verbal and written communications skills.Ability to work within a team and as an individual contributor in a fast-paced environment.Strong technical writing skills.Experience with root cause identification and problem solving.Strong organizational and follow-up skills, as well as attention to detail.Preferred QualificationsAdvanced degree preferred.Engineering experience and demonstrated use of Quality tools/methodologies.Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.Strong project management and leadership skills.Prior medical device experience.ASQ CQE or other certifications.Apply Now* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan.Learn more about our health and wellness benefits:
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.The base pay for this position is
$57,300.00 – $114,700.00In specific locations, the pay range may vary from the range posted.JOB FAMILY:
Operations QualityDIVISION:
EP ElectrophysiologyLOCATION:
United States > Minnesota > Plymouth: 5050 Nathan Lane NWORK SHIFT:
StandardTRAVEL:
NoMEDICAL SURVEILLANCE:
Not ApplicableSIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods, Keyboard use (greater or equal to 50% of the workday).
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Working at AbbottAt 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.Free medical coverage for employees* via the Health Investment Plan (HIP) PPO.An excellent retirement savings plan with high employer contribution.Tuition reimbursement and other educational benefits.A company recognized as a great place to work in dozens of countries.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.The OpportunityThis position works out of our Plymouth, MN location in the Electrophysiology division. As the Supplier Quality Engineer II, you’ll be responsible for activities related to new product development, supplier selection, 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 OnCore team supplier quality lead for EP new product development projects.Provides guidance and training to Purchasing, R&D, Manufacturing, and Quality engineers in applying program requirements.Identifies supplier contacts and solicits required documents from suppliers.Tracks supplier responses and conducts follow-up and escalation as necessary.Conduct phone calls with suppliers 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 and inspection procedures.Assesses supplier capabilities through direct visits and quality system audits.Proactively communicates quality issues to suppliers as needed.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.Works with Manufacturing engineering to assess and address purchased product issues.Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.Design and conduct experiments for process optimization and/or improvement.Participate in or lead teams in supporting Supplier Development Quality program requirements.Mitigates risk by working with suppliers to document Process Flow Charts, PFMEAs, and Control Plans.Complies with U.S. Food and Drug Administration (FDA) regulations and company policies.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.Performs other related duties and responsibilities, on occasion, as assigned.Required QualificationsBS degree in Engineering or Technical Field or equivalent experience.2-5 years Medical Device and/or Engineering experience.Ability to work in a highly matrixed and geographically diverse business environment.Strong verbal and written communications skills.Ability to work within a team and as an individual contributor in a fast-paced environment.Strong technical writing skills.Experience with root cause identification and problem solving.Strong organizational and follow-up skills, as well as attention to detail.Preferred QualificationsAdvanced degree preferred.Engineering experience and demonstrated use of Quality tools/methodologies.Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.Strong project management and leadership skills.Prior medical device experience.ASQ CQE or other certifications.Apply Now* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan.Learn more about our health and wellness benefits:
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.The base pay for this position is
$57,300.00 – $114,700.00In specific locations, the pay range may vary from the range posted.JOB FAMILY:
Operations QualityDIVISION:
EP ElectrophysiologyLOCATION:
United States > Minnesota > Plymouth: 5050 Nathan Lane NWORK SHIFT:
StandardTRAVEL:
NoMEDICAL SURVEILLANCE:
Not ApplicableSIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods, Keyboard use (greater or equal to 50% of the workday).
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