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 ensuring that the development team is compliant with the policies and procedures of Farm’s quality management system (QMS). The Supplier Quality Engineer receives direction from the Director of Quality and input from Program Managers and program team members.

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.
  • Facilitate selection of suppliers to support late-stage development and clinical 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.
  • Develop program supplier and incoming inspection plans for late-stage development and clinical builds based on input from program managers, engineers, suppliers and customers.
  • Plan and support test method and process validation activities completed by suppliers.
  • Complete incoming inspection and management of materials for late-stage development and clinical builds.
  • Manage site non-conforming material review process.
  • Lead supplier-related corrective action and preventive action resolution.
  • Manage site quality management system approved supplier list, supplier files and supplier performance metrics.
  • 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.
  • Analytical thinking, plus verbal and technical writing skills.
  • Demonstrated team collaboration experience.
  • Previous medical device industry experience/ ISO13485 (prefer).

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