Leo Khmelnitsky Email & Phone Number | • Quality Engineering and Material Safety professional with 13+ years of experience in quality and medical device industry structured within the ISO 13485. Possessing strong working knowledge within ISO 10993-1 body of knowledge and regulatory environment. Having extensive experience in CAPA resolution with continuous improvement of quality systems, product and process development with design verification, validation activities. I recently have expanded my responsibilities to include fulfilling the interim role of material safety as it pertains to all Medela products and markets. In this role, I have successfully delivered all ongoing business activities and projects with respect to ensuring timely material compliance to local, federal and international regulatory standards while increasing my working knowledge of ISO 11135 and 11137 standards. Possessing strong leadership and excellent communication skills. Review and analysis of all quality metrics to assess trending, product alerts, and risk aversion. Effective in team building and determining paths for getting the job done. Strong attention to small detail. Possessing thorough understanding and experience in quality control and assurance under lean sigma manufacturing methodology.

Leo Khmelnitsky

• Quality Engineering and Material Safety professional with 13+ years of experience in quality and m...
Chicago, Chicago, United States

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Leo Khmelnitsky’s Phone Numbers +1 815-363-****

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Leo Khmelnitsky’s Location Chicago, Chicago, United States

Leo Khmelnitsky’s Current Industry Medela

Leo Khmelnitsky’s Prior Industry Nypro A Jabil | Nanosphere | Stepan | Abbott

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Leo Khmelnitsky is a • Quality Engineering and Material Safety professional with 13+ years of experience in quality and medical device industry structured within the ISO 13485. Possessing strong working knowledge within ISO 10993-1 body of knowledge and regulatory environment. Having extensive experience in CAPA resolution with continuous improvement of quality systems, product and process development with design verification, validation activities. I recently have expanded my responsibilities to include fulfilling the interim role of material safety as it pertains to all Medela products and markets. In this role, I have successfully delivered all ongoing business activities and projects with respect to ensuring timely material compliance to local, federal and international regulatory standards while increasing my working knowledge of ISO 11135 and 11137 standards. Possessing strong leadership and excellent communication skills. Review and analysis of all quality metrics to assess trending, product alerts, and risk aversion. Effective in team building and determining paths for getting the job done. Strong attention to small detail. Possessing thorough understanding and experience in quality control and assurance under lean sigma manufacturing methodology.