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Senior Supplier Development Quality Engineer

Company: Abbott Laboratories
Location: Saint Paul
Posted on: May 14, 2022

Job Description:

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 113,000 colleagues serve people in more than 160 countries.Structural Heart Business Mission: why we existOur business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of careOur team in St Paul, MN has an opening for Supplier Development Quality Engineer to be responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet company and regulatory requirements. What you will do:

  • Contributes to the development, maintenance and improvement of division supplier development quality program policies, procedures and forms.
  • May provide coaching, and mentoring for technical team personnel.
  • Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements.
  • Reviews and approves all supplied product drawings and component quality plans.
  • Manages development of supplied product inspection procedures and first article requirements.
  • Provides engineering guidance to division 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 partnerships with suppliers
  • Applies sound engineering analysis and judgment to reduce the need for inspection in accordance to program policies.
  • 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 (e.g., represent the Supplier Development Quality function as a Core Team Member)
  • 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.Qualifications:
    • Bachelors Degree in Engineering or Technical Field or equivalent combination of education and work experience
    • Masters Degree preferred
    • Min 5 years of Related experience Prior medical device experience preferred.
    • Demonstrated supervisory experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies.
    • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971. Solid communication and interpersonal skills.
    • 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.
    • Advanced computer skills, including statistical/data analysis and report writing skills.
    • Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
    • ASQ CQE or other certifications preferred.
    • Experience working in a broader enterprise/cross-division business unit model preferred.
    • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
    • Ability to travel approximately 10-40%, including internationally.WHAT WE OFFERAt Abbott, you can have a good job that can grow into a great career. We offer: - A fast-paced work environment where your safety is our priority (Manufacturing roles only) - Production areas that are clean, well-lit and temperature-controlled (Manufacturing roles only) - Training and career development, with onboarding programs for new employees and tuition assistance - Financial security through competitive compensation, incentives and retirement plans - Health care and well-being programs including medical, dental, vision, wellness and occupational health programs - Paid time off - 401(k) retirement savings with a generous company match - The stability of a company with a record of strong financial performance and history of being actively involved in local communitiesLearn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspxFollow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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.

Keywords: Abbott Laboratories, St. Paul , Senior Supplier Development Quality Engineer, Engineering , Saint Paul, Minnesota

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