Full Job Description
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
