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).