• 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.

• 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.

• American Society for Quality (ASQ) Certified Quality Engineer (CQE).
• ISO 13485 Internal or Lead Auditor Training.

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