 Leadership: Considered the US Quality Authority – Department responsibilities include but not limited to internal and external audits, supplier management, DHR review and batch release, Document Control/Records Management, NC/CAPA, Complaints, Change Management including new products and materials, Risk Management, Training program, Quality Control Lab Serves as Person Responsible for Regulatory Compliance (2017/745 EU Medical Device Regulation) and Management Representative (ISO 13485:2016) Relationships: Achieves compliance and business results through Partnerships between Quality and Operations and other site/cross site functions. Is an active key member of the US Leadership Team. High Performance Culture: Creates a high achieving Quality & Compliance team with goals and values global operations, collaborative team environment, and high-performance culture making decisions based on risk following ISO 14971.  Talent Management Focus: Oversees the conduct of Talent Management programs to develop future leaders and the creation of robust succession plans for the Site Quality and Compliance Organization. Directs, oversees and participates in the recruitment, selection, promotion, termination and performance management of site personnel in leadership and critical roles. Leads the following activities: Job Descriptions, Training curricula, Development plans, Performance appraisals, Performance coaching Regulatory Excellence: Ensures sustainable regulatory excellence through systems, science, people, and continuous process improvements. Ensures a favorable site regulatory profile through constant inspection readiness programs; ensures successful inspections. Creates effective relationships with regulatory agencies to create trust and credibility. Prepares the site for changes to regulations. Quality Systems: Ensures and effective and compliant site Quality Management Systems are in place. Develop new systems as new products/processes are implemented.

 Led the evaluation of adequacy and compliance of the site QMS against all applicable medical device/combination product regulations and company policies and procedures. Led/Support EU MDR transition activities  Responsible for Supplier Quality Management Developed and tracked inspection readiness metrics and ensures positive site outcomes post-inspections. Served as device Management Representative in preparation for Management Review Meetings with timely inputs as required for Sr. Management escalation. Ensured the inspection readiness of the site at all times and compliance with all applicable regulations within the scope of the manufacturing site’s activities. Managed quality systems improvement plans and ensures timely escalation of issues. Kept track of ongoing industry quality and regulatory compliance matters applicable to device/combination products at the site and ensures required updates are implemented in a timely manner.

Leads/Supports EU MDR transition activities. Supports the development, implementation and monitoring of Quality and Regulatory Compliance strategies at the site for medical devices. Ensures the inspection readiness of the site at all times and compliance with all applicable regulations within the scope of the manufacturing site’s activities. Manages quality systems improvement plans and ensures timely escalation of issues.*Leads the evaluation of adequacy and compliance of the site QMS against all applicable medical device/combination product regulations and company policies and procedures.*Develops and tracks inspection readiness metrics and ensures positive site outcomes post-inspections.*Supports device Management Representative in preparation for device Management Review Meetings with timely inputs as required for Sr. management escalation.*Keeps track of ongoing industry quality and regulatory compliance matters applicable to device/combination products at the site and ensures required updates are implemented in a timely manner.*Supports other identified compliance related activities as needed.

•Communicate on quality objectives, targets and policy issues•Assist in and/or lead up MIR investigations•Provide direction and guidance in resolution of technical issues. Assist in problem solving•Employ and champion the use of Quality Risk Management (QRM) and Risk Assessment (RA) Techniques (e.g. FMEA, Fault Tree Analysis)•Act as QRM Facilitator, leading up and/or participating in QRM/RA activities•Responsible for review of corporate, regulatory & other procedures, assess requirements for implementation•Review & approval of Standard Operating Procedures as applicable•Participation in audit programs as required•Participation in validation of plant & equipment •Assist in the development of GMP training programs, schedules & delivery of training•Attendance at weekly SBU& Quality departmental meetings•Communicate all quality issues within the SBU to both Operation & Quality Management.•Assist in HACCP•Ensure that all CAPAs (Corrective Actions, Preventive Actions) are completed as expected•Continuous improvement:•Adhere to relevant PQS & industry standards•Participate with Corporate communities of practice and quality forums to ensure compliance of the Askeaton site while providing SME (Subject Matter Expert) lead on some initiatives•Lead and/or participate in projects in areas of yield loss improvement, efficiency, lean processes, metric improvement, quality system improvement•Devise methods to improve develop and improve quality standards and work practices within the plant

Documentation and Procurement

Member of the Service Team at corporate location. Provided front line customer and internal field service support within the Bruker Nano Surfaces Business Customer Care Center reporting to the Sr. Customer Support Manager, Americas. Effectively managed the transfer of technical requests to regional Technical Support team.Responsible for tracking, and clearing issues in order processing and release: Commit dates, RMA’s, demo shipment request, material requisition approval and processing.Received direct customer and internal field service communication through phone, e-mail, website, and SAP database and processed these requests in the most effective and efficient manner. Answered domestic/international interoffice inquiries and communicated with BU’s cross-functional partners.Trained on Export Compliance procedures. Reviewed and cleared orders for Export as well as orders shipping back to the factory through FedEx, UPS, DHL which became stuck in customs.Evaluated current SOP for processing orders in SAP. Provided recommendations for processing non-standard requests in SAP.Executed data analysis as requested by the Customer Support Manager using SAP. Exported data to Excel, created pivot tables and used macros to provide 1st level analysis.Generated quotes, created sales orders, executed order review. Processed completed repairs.Managed Asset Recovery for North and South America. Reduced asset recovery from >$250,000 in assets outstanding over 60 days to $0.Trigger invoicing for FSE on-site visits and installations.

• Member of the Retention Sales Team at corporate location. • Trained additionally to be Sales Support for department. • Met and exceeded monthly sales quota. • Retained and managed over 2000 business accounts in Lubbock and surrounding areas totaling over $220,000 MRC. • Established relationships with new accounts from within base in the West Texas region • Demonstrated stellar communication and negotiation skills through sales closings of accounts, preparation of quotes, and the resolution of problem accounts. • Enjoyed talking to people and establishing a long-term, loyal customer base. • Processed incoming orders, handled customer-related issues. • Developed and presented effective sales presentations for new accounts. • Plan and direct activities such as sales promotions with manager as required. • Worked with a team of sales people to achieve maximum revenue for Business Sales department.

• Dispatch service and maintenance calls to servicemen daily. • Determine staffing requirements, and interview, hire and train new employees. • Direct and coordinate financial activities and budget to fund operations, maximize investments, and increase efficiency. • Establish and implement departmental policies, goals, objectives, and procedures. • Manage staff, preparing work schedules and assigning specific duties. • Plan and direct activities such as sales promotions with other manager as required. • Review financial statements, sales reports, and other performance data to measure productivity and goal achievement and to determine areas needing cost reduction and program improvement. • Reconciling monthly activity, generating year-end reports, and fulfilling tax related requirements.

• Managing member of Watersall’s profit based Andrew H. Jordan Foundation for Children: non-profit organization to raise awareness for chilhood obesity. • Manage payable and receivable accounts using QuickBooks. • Maintain and update three company websites. • Responsible for all customer service issues. Develop and implement customer service policies. • Contributed in non-profit organization’s start-up and continuance. • Manage the interactions of over 50 Watersall, Inc. representatives across the United States and administer commission statements. • Monitor and maintain annual budget. • Assist with implementing marketing strategies. • Provide direct assistance to the President and Vice President of Watersall, Inc. • Book flights, hotels, in-store visits, trade shows, and manage personal engagement details for President of Watersall, Inc.