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Supplier Quality Engineer II

2 months ago

Minneapolis, Minnesota, United States Abbott Laboratories Full time
About the Role

Abbott Laboratories is seeking a highly skilled Supplier Quality Engineer II to join our team in Plymouth, MN. As a key member of our Electrophysiology division, you will play a critical role in advancing the treatment of heart disease through breakthrough medical technologies.

Key Responsibilities
  • Lead supplier quality activities related to new product development, supplier selection, evaluation, material qualification, supplier performance, and receiving inspection.
  • Contribute to the development, establishment, and maintenance of supplier quality engineering methodologies, systems, and practices that meet Abbott and regulatory requirements.
  • Provide guidance and training to Purchasing, R&D, Manufacturing, and Quality engineers in applying program requirements.
  • Identify and solicit required documents from suppliers, track supplier responses, and conduct follow-up and escalation as necessary.
  • Conduct phone calls with suppliers to expedite responses or answer questions.
  • Review current Quality Agreements and determine the need to revise them.
  • Obtain and analyze performance and quality indications information from internal sources for each supplier.
  • Prepare and submit required quality records and documents for closure and filing.
  • Review and approve all supplied product drawings and component quality plans.
  • Manage the development of supplied product inspection procedures and first article requirements.
  • Provide engineering guidance to Abbott Receiving Inspection, including statistical analysis, measurement techniques, Gage R&R studies, and inspection procedures.
  • Assess supplier capabilities through direct visits, technical discussions, directed testing, and quality system audits.
  • Proactively communicate quality issues to suppliers through supplier quality system audits, supplier corrective action requests, and technical discussions.
  • Evaluate and develop Supplied Data Agreement, Skip Lot, Dock-to-Stock, CoC, and CoA partnerships with suppliers.
  • Apply sound engineering analysis and judgment to reduce the need for inspection in accordance with program policies.
  • Work with Manufacturing engineering to assess and address purchased product issues.
  • Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
  • Design and conduct experiments for process optimization and/or improvement.
  • Participate in or lead teams in supporting Supplier Development Quality program requirements.
  • Mitigate risk by working with suppliers to document Process Flow Charts, PFMEAs, and Control Plans.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Contribute to the development, maintenance, and improvement of Abbott supplier development quality program policies, procedures, and forms.
  • Perform other related duties and responsibilities, on occasion, as assigned.
Requirements
  • BS 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.
  • 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.
  • 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 technical writing skills.
  • Experience with root cause identification and problem solving.
  • Multitasks, prioritizes, and meets deadlines in a timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
Preferred Qualifications
  • Advanced 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, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
  • Prior medical device experience.
  • ASQ CQE or other certifications.
About Abbott Laboratories

Abbott Laboratories 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.

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.
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO.
  • 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 bachelor's degree.
  • 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.
  • 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.

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.