Senior Quality Engineer - Medical Device Industry

Must Have Technical/Functional SkillsKnowledge of Quality Management Systems and applicable quality tools and techniquesKnowledge of GMP, FDA Quality System requirements, ISO 13485 and applicable compliance regulationsKnowledge of medical device regulatory standards, including design control and risk management requirementsKnowledge of NC, CAPA, deviation, Root Cause Analysis, change control and audit processesKnowledge of statistics, Risk Management, Design Control and process validationExperience creating and reviewing DFMEA, PFMEA, risk management records, protocols and technical reportsExperience with verification and validation documentation and IQ/OQ/PQ activitiesExperience with Post Market Surveillance and quality trend evaluationExperience with PLM/eQMS tools; Windchill experience is preferredGood understanding of engineering drawings, specifications, tolerances and GD&T