Karen Tolson

• Senior Director of Quality Systems and Analytics is responsible for creation and implementation of defect identification process, issue correction and containment, root cause determination, and corrective/preventive actions. Primary focus is driving continuous improvement in all functions with heavy emphasis on product surveillance and operational excellence. Senior Director is also responsible for determination and reporting of cost of quality for all products including trend identification.

Key Accomplishments:

• Configured and implemented off the shelf defect reporting tool in first 70 days of starting the role including user training. To date the tool has over 9000 active users and has provided over 200,000 data records.
• Implemented business wide complaint handling process resulting in improved customer satisfaction as measured through Net Promoter Score (NPS). Increased cross functional issue resolution closure rate from 55% to 98% while decreasing resolution cycle time from 110 days to 21 days.
• • Led customer quality-focused improvement programs leveraging defect data to identify areas to target resources to resulting in 20% year over year CoPQ improvement and over $85 million in cost savings to the business.
• Received the Business Impact Award
• Received Women in Supply Chain Forum Award from the Women in Supply Chain Forum

• Developed and implemented innovative strategy and execution plan for categorization and prioritization of internal and external non conformances for all products in Grid Automation business.
• Responsible for the execution and validation of programs that support GE Digital Energy Quality Strategy and ensured program outputs were compliant with GE Digital Energy Quality Management System and applicable regulations (ISO 9001, Measurement Canada, MID, etc.).
• Led team to receive the first MID Certificate for General Electric and ISO Certification of new production facility in Bilbao, Spain

• Developed and implemented the post market compliance strategy in response to a FDA warning letter for all 12 products in the GE Healthcare Information Technology portfolio.
• Responsible for the execution of non-conformance investigations and the validation of corrective and preventive actions.
• Developed and implemented a global post market surveillance organization.
• Led FDA audit to resolve warning letter with zero findings

• Class II medical device
  Developed a process for the evaluation and prioritization of post market non conformances.
• Led the post market response to an FDA consent decree for a global class II medical device. Responsible for the evaluation, prioritization, and reporting of post market non conformances in addition to the reporting and execution of field recalls.
• Fulfilled the role of post market compliance representative for global regulatory agencies including the FDA, Health Canada, BfArM, and SFDA.
• Received CEO Award for business impact
• Received Engineering Quality Champion Award

• Managed product defect control mechanisms for 7 products distributed in 20 countries
• Drove the identification and resolution of product defects.
• Developed and provided training for all staff members of quality systems and regulatory requirements
  

• Managed a $50,000,000 business on a global scale
• Selected products and vendors to incorporate into the GE CR portfolio. Led CR vendor negotiations for the single largest PAC's sale in the history of GE.
• Authored multiple white papers on various topics related to computed radiography.
• Developed and implemented strategy for exit of a private label product strategy and move to a multi vendor portfolio. Grew
• CR business for GE from $20,000,000 to $50,000,000 per year.

• Provided customer training/support on computed radiography systems and Radworks.
• Provided post sales and post installation support for multiple products.
• Contributed to development of customer teaching materials, written and video

• Developed customer requirements documents and product roadmaps.
• Served as product commercialization gatekeeper
  Serviced as the interface between operations and marketing
• Responsible for competitive assessments.
• Responsible for the inclusion of customer response into the product portfolio.
• Instrumental in working with marketing and engineering in launching a new product

• Provided product training to sales force on multiple products.
• Provided pre installation and pre sales support for multiple products.
• Conducted trade trials of multiple new products.
• Participated in core teams to facilitate launching new products into the market place
• Provided design/product input into the development of the sales quoting too

• Provided customer training/post installation support for digital medical imaging products
• Assisted customers in evaluating workflow and the efficient use of digital equipment
• Served as staff for numerous trade show and multiple imaging products.
• Selected for international assignment