Quality Engineer - Medical Device

Knowledge of Quality Management Systems and applicable quality tools and techniques

Knowledge of GMP, FDA Quality System requirements, ISO 13485 and applicable compliance regulations

Knowledge of medical device regulatory standards, including design control and risk management requirements

Knowledge of NC, CAPA, deviation, Root Cause Analysis, change control and audit processes

Knowledge of statistics, Risk Management, Design Control and process validation

Experience creating and reviewing DFMEA, PFMEA, risk management records, protocols and technical reports

Experience with verification and validation documentation and IQ/OQ/PQ activities

Experience with Post Market Surveillance and quality trend evaluation

Experience with PLM/eQMS tools; Windchill experience is preferred

Good understanding of engineering drawings, specifications, tolerances and GD&T

Experience supporting neurovascular, catheter-based, implantable or other Class II/Class III medical devices is