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Karen Wagener
Former Senior Quality Assurance Executive - Elektra

Ms. Wagener is a senior Quality Assurance/Regulatory Affairs Executive with a proven ability to develop and implement strategies and programs that result in operational efficiency gains, improved culture of quality and employee satisfaction, and successful market access for a diverse mix of products. She has a degree in Chemical Engineering from Washington University in St. Louis and has experience in biopharmaceutical, chemical, medical device, software, automotive and service industries. 

As Vice President of Global Quality Assurance at Elektra, Ms. Wagener developed and managed the strategy to implement a harmonized business management system to standardize and streamline the existing nineteen quality systems within Elekta. She also sponsored and implemented a global electronic document management system resulting in over $500,000/year in cost savings and efficiency gains. Ms. Wagener spearheaded a Culture of Quality program for the QA/RA function to improve communication and employee satisfaction.

Ms. Wagenerʼs Regulatory Affairs background includes developing and executing submission strategies for both hardware and software medical devices and ensuring compliance with privacy, security and export control regulations. She increased sales and revenue opportunities with successful market access activities in China, Europe, Canada and the United States.

Ms. Wagener has a wide range of experience and is particularly adept in multinational and multi-cultural environments. She has experience leading and developing virtual teams and has a track record of creating a positive and productive work environment.

Her areas of expertise include:
Quality Assurance | Regulatory Affairs | Continual Improvement | Quality Culture Development | Systems Development and Integration | General Management | Leadership | Team Building/Development | Consulting