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Senior Quality Engineer

Farm is seeking a Senior Quality Engineer to support product development as an embedded program team member working alongside program managers, researchers, human factors engineers, designers, mechanical engineers, and electrical engineers.

Here is a glimpse of what you’ll do…
  • Provide guidance to program teams on compliance with the quality management system.
  • Assist program managers with development, review, approval, and updates to program documents.
  • Assist program managers with development, review, and updates to program and quality planning documents.
  • Collect and manage content of program design history files (DHF).
  • Review applicability of customer product requirements and risk management documentation to programs and deliverables.
  • Coordinate milestone and technical reviews with program teams.
  • Work with program teams for planning and documentation for prototype builds including, but not limited to control of the design; development of build plans; acceptance of materials and documentation of assembly processes.
  • Lead planning and documentation for prototype testing including, but not limited to creation of test plans; development of test methods; coordination of data collection, analysis & audit, and completion of test reports.
  • Manage quality management system processes including, but not limited to training records, calibration records, supplier records, engineering change orders (ECO) and documentation control.
  • Establish, evaluate, qualify, encourage use of and continuous improvement to processes, procedures and standard tools used by program teams.
  • Participate in internal, customer and notified body audits of the quality management system.
  • Lead corrective action and preventive action resolution.
Here is some of what you’ll need (required)...
  • Bachelor’s Degree in engineering, science, or equivalent technical discipline.
  • 8 + 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.
Here are a few of our preferred experiences...
  • American Society for Quality (ASQ) Certified Quality Engineer (CQE).
  • ISO 13485 Internal or Lead Auditor Training.

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