Supplier Quality Engineer

1915S Requisition #
This position assures company compliance to all pertinent United States F.D.A., state, and international regulatory requirements which are applicable to the design, manufacture and distribution of medical and diagnostic devices by performing the following duties:

  • Conducts activities concerned with the quality assurance of a given commodity set by working closely with suppliers, manufacturing, purchasing, and supplier quality.
  • Through the MRB process and other inputs investigates supplied-product quality nonconformances and issues supplier corrective actions to ensure appropriate containment steps and corrective actions are taken in a timely manner. Works with suppliers to confirm corrective action plans are effective.
  • Reviews performance scorecard metrics and issues scorecards to assigned suppliers (by commodity) on a quarterly basis to verify status and outline action items necessary for improvement.
  • Responsible for identifying and resolving specification alignment issues between manufacturing (process), engineering requirements and supplied product. 
  • Conducts and documents regular visits/audits to assigned suppliers to review manufacturing processes, quality systems / controls, pre-launch readiness, root cause identification, corrective actions, and process improvement opportunities.
  • Serves as lead for Supplier Request for Change process.
  • Actively works with Global Sourcing in new supplier selection and qualification.
  • Meet company and department goals in continuous improvement of all products, services, and processes.
  • Participate in New Product development teams and Component Qualification Process as needed to carry out approvals for given components.

  • None

  • Bachelor's degree (B.A.) from four-year college or university preferred; or two to five years related experience and/or training; or equivalent combination of education and experience.

  • Familiarity with ISO 13485 and 21 CFR 820 especially on Purchasing Controls
  • Process validation and test method qualification
  • Auditing to Quality Systems and Manufacturing processes
  • Root cause investigation

  • None

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