Senior Quality Assurance Engineer

7 days ago

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

Abbott Laboratories is seeking a highly skilled Senior Supplier Quality Engineer to join our Electrophysiology division in Plymouth, MN. As a key member of our team, you will be responsible for providing expertise in supplier selection, evaluation, and qualification, as well as ensuring compliance with regulatory requirements.

Key Responsibilities
  • Provide guidance and training to Purchasing, R&D, Manufacturing, and Quality engineers in applying program requirements
  • Perform re-assessment of suppliers each year per a defined schedule
  • Identify supplier contacts and solicit required documents from suppliers
  • Track supplier responses and conduct follow-up and escalation as necessary
  • Conduct phone calls with suppliers as needed to expedite responses or answer questions
  • Review current Quality Agreements and determine need to revise
  • Solicit revised Quality Agreements as determined
  • 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 as needed through supplier quality system audits, supplier corrective action requests, and technical discussions
  • Participate and provide engineering ownership for all supplied product Non-Conforming Material Reviews
  • Contribute and participate in supplier performance reviews
  • 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
  • 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
Requirements
  • BS 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 Qualifications
  • Advanced 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
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
  • An 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
  • 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

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 $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.

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