Senior Manager, Quality Devices & Compliance

Job Summary: Quality Devices: Leads all the quality aspects for medical devices development, manufacturing, release and life cycle management in accordance to regulatory requirements and UroGen Quality System requirements. Quality Compliance: Owner of Quality Management System (QMS), ensure compliance to regulatory requirements (cGMP/QSR/PQS/ISO13485) across the company and functions, lead and manage the Quality Compliance team. Duties & Responsibilities  Quality Devices  Ensure quality assurance support to development, production and product engineering of medical devices according to QSR/cGMP and ISO13485 requirements, regulations and guidelines for different markets.  Provide support to the medical devices Change Controls to ensure correct implementation of change control procedures pertaining to products, contract manufacturing and quality control facilities, etc.  Provide support in conducting quality audits of suppliers / vendors for medical devices, including as may be required raw material manufacturers, contract manufacturers, packaging materials manufacturers, contract laboratories etc. for the purpose of evaluation and approval.  Participate in preparation/review/approval of protocols and reports of studies pertaining to the drug or device products, the product transfer from R&D to manufacturing, the production processes, the equipment and systems of the manufacturing and quality control laboratories.  Quality Compliance  Owner of QMS and related processes, including CAPA, Deviations, Complaints, Risk Management, Audits (internal/external), Management Review, etc.  Provide support in training manufacturing, engineering, quality control and other personnel on the various relevant aspects of quality assurance.  Provide support in handling all customer complaint issues, including the complaint investigation, the reporting to regulatory authorities as required, feedback to the customer.  Lead and support quality improvement programs throughout the Company.  Perform any other related duties as management may require from time to time.