- Direct report to the CEO and member of Senior Leadership Team.- Lead team of 10 in Quality Control, Quality Assurance & Regulatory, and Supplier Quality for entire organization.- Develop departmental strategy and maintain budget for Quality department, including equipment and expenditures for process and personnel improvement.- Manage budget to maintain internal talent, maximize efficiency and reduce redundancies via training, equipment upgrades and process improvements.- Lead and improve CAPA and Audit systems to ensure organizational compliance.- Establish measurable metrics in order to set and meet organizational goals while maintaining individual accountability for contributions.- Manage and facilitate customer relationships in matter s pertaining to quality and productivity.- Develop and implement individual level training plans for 100 staff across 3 facilities. Provide on-the-job training to ensure responsibilities are defined, understood, and focused on improvement.- Contribute to design and development projects as expert in quality control and regulatory requirements.- POC for FDA and auditing bodies.

- Manage a 6 person production team.- Manage 4 production cells for medical product.- Manage Class 8 cleanroom compliance.- Manage all customer facing interactions.- Manage supply chain and forecast production up to 3 months out to minimize downtime, properly allocate resources and equipment and ensure material availability

- Oversee sales and procurement activities for a wide range of products, including military rated materials- Commercial and military contract review, including verifying end user certificates for traceability purposes.- Product and document analysis for compliance current to ITAR, Department of State and Department of Commerce Regulations.- Execute financial duties including accounts payable and receivable transitions, financial statement review, bank account and credit card reconciliations.- Maintain office policies and procedures for conformance to ISO 9001 standard.- Monitor metrics, including on-time delivery statistics, supplier quality ratings, customer satisfaction scores, monthly sales, and profit and loss statistics.- Prepare and execute training activities for all personnel for new or changing procedures and product knowledge.- Schedule and execute audits to monitor conformance to procedure.- Monitor shipping and receiving of product for compliance, including segregation and disposition of non-conforming materials.- Resolve product problems by tracking and analyzing returned materials.- Initiate and complete corrective and preventive action activities.- Manage and maintain customer and vendor databases.- Management of President's personal and business calendar.- Coordinate staff travel arrangements.