Sr. Manager, Quality Kalila
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About The Position
Senior Manager, Quality has primary responsibility for establishing and maintaining compliance of Kalila Medical's (KMI) processes and procedures to the FDA (US) and PMDA(Japan) Quality System Regulations, and ISO 13485. This role will manage, lead and mentor the Kalila Medical Quality team. Senior Manager, Quality will manage and maintain compliance for quality systems as defined in the company's Quality Manual including Management Oversight, Supplier Controls, Equipment Controls, Nonconformance Management, CAPA, Complaint Handling and Adverse Event Reporting, Corrections and Removals, Document Control, Lot Release, Training, Production & Process Control, Design Controls/Assurance, Risk Management etc. Senior Manager, Quality will manage the collection, analysis, maintenance and presentation of quality data/metrics to monitor and assure the overall suitability and effectiveness of KMI's Quality System. Shall develop and implement strategies and supporting initiatives to promote the effectiveness and continual improvement of KMI's Quality Management System. Senior Manager, Quality will be a collaborative member on the KMI Leadership Team and will serve as the Management Representative for KMI. In addition, will be a member of Terumo Medical Corporation (TMC) Quality Management Leadership Team and will be responsible to drive coordinated activities across TMC operations. Senior Manager, Quality will also provide Quality Engineering / Design Assurance support to R&D as they develop products for commercialization through KMI's Quality Management System. Salary range: $148,200 - $224,200 and 15% bonus.
