INTERSECT ENT – $123,261.00/Year

This position requires a Masters degree or foreign equivalent in Life Sciences, Chemistry, Engineering, or in a closely related field, plus 2 years of work experience in Medical Device andor Pharmaceutical Industry.br br REQUIRED EXPERTISEKNOWLEDGE 1. Ensure compliance of products with combination drugdevice regulations and guidance from Food and Drug Administration FDA 2. Supporting production and design quality in medical device or pharmaceutical industries. 3. Working on all phases of Corrective and Preventive Actions CAPA including investigation, action, effectiveness, and closure. 4. Ensure compliance of quality system procedures with applicable risk management standards, and quality system regulations from Food and Drug Administration FDA and International Organization for Standardization ISO. 5. Conducting postmarket monitoring of medical devices or pharmaceuticals, including Medical Device Reports MDR, Complaint Handling, Risk Management, and Recall.br br MUST POSSESS EXPERTISE KNOWLEDGE SUFFICIENT TO ADEQUATELY PERFORM THE DUTIES OF THE JOB BEING OFFERED. EXPERTISE KNOWLEDGE MAY BE GAINED THROUGH EMPLOYMENT EXPERIENCE OR EDUCATION. SUCH EXPERTISE KNOWLEDGE CANNOT BE quot;QUANTIFIEDquot; BY quot;TIME.quot;br br Telecommuting Permitted.