ATEK Medical Hires for New Regulatory and Quality Position

GRAND RAPIDS, MICH. (July 24, 2008) – ATEK Medical, a division of ATEK Companies, has hired Felix Le as director of quality and regulatory affairs. In this position, Le will be responsible for maintaining ATEK’s compliance with FDA regulations as well as international regulatory policies and overseeing the company’s continuous quality improvement processes.

 

“The medical industry is one of continuous improvements and consistently changing regulations,” said Chris Oleksy, president, ATEK Medical. “With the opening of our Costa Rican plant and increased production volume due to growth in our clients’ businesses, maintaining the highest levels of quality and regulatory compliance is essential. The addition of Le to the ATEK team solidifies our commitment to manufacturing the best product with the most efficient process, while still maintaining a highly controlled environment.”   

 

Le brings to ATEK more than two decades of experience in regulated industries — nearly 17 years of which he spent at Medtronic where he held positions of increasing responsibility. Most recently Le served as senior manufacturing and pharmaceutical quality manager for Medtronic’s neuromodulation business unit. Prior to Medtronic, he held a number of positions at FMC Corporation in its naval systems division. Additionally, Le is trained in SixSigma and is an ASQ certified quality auditor, quality engineer, software quality engineer and quality manager.

 

For additional information about ATEK Medical, please visit www.atekmedical.com

ATEK Medical is a total solutions partner serving the medical, disposable, electro-mechanical and implantable device markets. From product design and launch to distribution and post-production fulfillment, the ATEK Medical team is dedicated, skilled and cross-trained to serve your company’s needs. ATEK Medical capabilities include product development and launch; medical device manufacturing; packaging, labeling and sterilization services; microbiology services; supply chain management; and post-production fulfillment services. ATEK Medical is ISO 13485:2003 certified and FDA registered to design, produce and launch Class I, II and III medical devices. Since 1979, ATEK Medical has developed and launched more than 300 unique products and specializes in product management and full-service manufacturing. For more information on ATEK Medical, visit www.atekmedical.com

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