1+ months

Supplier Development Quality Engineer II

Plymouth, MN

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

A Supplier Quality Engineer drives improvement in the quality of components and services sourced from external suppliers. Provides technical support in the selection and evaluation of suppliers, monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.
Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet SJM and regulatory requirements.

Job Description:

  • Contributes to the development, maintenance and improvement of SJM 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 SJM 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 judgement 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.
  • Performs other related duties and responsibilities, on occasion, as assigned

    General Qualifications:

    • BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred
    • 2-5 years of experience
    • Engineering experience and demonstrated use of Quality tools/methodologies
    • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
    • Solid communication and interpersonal skills
    • Advanced computer skills, including statistical/data analysis and report writing skills
    • Prior medical device experience preferred
    • ASQ CQE or other certifications preferred
    • Experience working in a broader enterprise/cross-division business unit model preferred.
    • Ability to work in a highly matrixed and geographically diverse business environment.
    • 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 verbal and written communications with ability to effectively communicate at multiple levels in the organization.
    • Ability to travel approximately 10-20%, including internationally.

      Job Family: Operations Quality
      Division: CAHF Cardiac Arrhythmias & Heart Failure
      Travel: Yes, 20 % of the Time
      Medical Surveillance: Not Applicable
      Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)


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Supplier Development Quality Engineer II

Plymouth, MN

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Plymouth, MN

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