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Supplier Quality Engineer

Farm is seeking a Supplier Quality Engineer to join our talented and dynamic product development group and play a critical role in creating the next generation of advanced medical technologies. Responsible for supplier development in a manufacturing or service process; works with suppliers to continuously improve performance, implement process controls and develop quality assurance plans.

Here is a glimpse of what you’ll do…
  • Support product development as an embedded program team member working alongside program managers, researchers, human factors engineers, designers, mechanical engineers, electrical engineers and process engineers.
  • Lead program managers and engineers for the identification of suppliers to support concept and late-stage development prototype builds.
  • Qualify suppliers via capability questionnaires, risk assessment, supplier file creation/management and on-site audits.
  • Represent program teams for collaboration with corporate procurement and supply chain resources.
  • Collaborate with finance team to setup suppliers in corporate purchase request and purchase order systems.
  • Develop incoming inspection plans for concept and late-stage development build materials based on input from program managers, engineers and suppliers.
  • Plan and support test method and process validation activities completed by suppliers.
  • Complete incoming inspection and management of materials for controlled development builds.
  • Manage site non-conforming material review process.
  • Lead supplier-related corrective action and preventive action resolution.
  • Participate in activities pertaining to cycle time and process improvements.
  • Manage site quality management system approved supplier list, supplier files and supplier performance metrics for service and material suppliers.
  • Establish, evaluate, qualify, encourage use of and continuous improvement to supplier management processes, procedures and standard tools used by program teams.
  • Participate in internal, customer and notified body audits of the quality management system.
  • Interacts with customers, suppliers and external auditors to develop close working relationships.
  • Participates in customer strategy meetings and discussions regarding the development of program quality requirements and plans.
  • Participates in the technical review process on development programs.
Here is some of what you’ll need (required)...
  • Bachelor’s Degree in engineering, science, or equivalent technical discipline.
  • 4+ years of experience working in medical device product development.
  • Experience with ISO 13485, ISO 14971 & FDA 21 CFR 820.
  • Analytical thinking, plus verbal and technical writing skills.
  • Demonstrated team collaboration experience.
  • American Society for Quality (ASQ) Certified Supplier Quality Professional (CSQP) (Preferred).

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