Oversee and coordinate the administrative, legal, operational, and financial issues related to payor contracting. Evaluate profitability of proposed arrangements. Contract build, maintenance, testing, modeling, and analyzing of hospital and professional payor contracts in Epic. Evaluate opportunities and financial terms for hospital and physician contracts. Lead resolution of issues that arise between departments with insurers.

• Ensure that the quality management system (QMS) is implemented in accordance with the Keller Medical SOPs and applicable regulatory requirements, including 21 CFR 820, ISO 13485, European Medical Device Regulation, Health Canada and other international regulations.• Manage customer feedback process, perform complaint investigations and other post market surveillance activities.• Perform trending of complaint and quality indicators per established quality objectives.• Prepare documentation for Management Review, present data and issue meeting minutes.• Manage Document Control process. • Maintain and keep current all quality documents, lists, logs, and files.• Maintain quality system documents such as complaint files, document control files, and supplier files.• Manage the returned goods process.• Manage nonconforming materials process and maintain quarantined product.• Manage the internal CAPA and external Supplier Corrective Action (SCAR) process documentation. • Perform root cause analysis.• Maintain and keep current regulations and standards applicable to Keller Medical.• Perform quality inspections.• Perform product release and including review of ethylene oxide sterilization documentation.• Perform internal and external quality system audits.• Perform annual supplier evaluations.• Maintain approved supplier list.• Maintain employee training records. Track and coordinate annual employee training and competency reviews.• Perform training on new and revised documents.• Maintain and track preventive maintenance and calibration schedules. • Prepare documents for regulatory submission. Liaise with distributors to provide regulatory documentation for submission to their respective countries. • Maintain the Technical File.• Act as Project leader of Design Control activities.• Review and revise Risk Management file in compliance with ISO 14971.• Coordinate clinical evaluation.

• Manage all international sales for gift division- both on the retail level and distributor level for fifteen plus countries.• Seek out new distributors and negotiate contracts.• Coordinate shipments from both USA and China warehouses.• Manage twenty plus sales representatives for the Kid Tee and Stephen Joseph Gift operations in Canada.• Frequently travel to wholesale tradeshows and manage tradeshow travel, arrangements and booth setup for company.• Make site visits to distributors in their home countries.