
lumi skiba
director of operations
About
20 years experience in leading Quality Assurance positions in the medical device industry. Since 2015, holding the position of Director of Operation at Vomaris Innovations, Inc.
united states
tempe
medical devices
fda, quality assurance, iso 13485, quality system, capa, validation, v&v, quality management, regulatory submissions, medical devices, regulatory affairs, quality auditing, gmp, design control, quality control, 21 cfr part 11, fda gmp, contract manufacturing, internal audit, change control, complaint management, sterilization, glp, sop, ce marking, u.s. food and drug administration
Experience

quality assurance manager
t.a.g medical

quality assurance manager
precise medical products pmp

quality assurance manager
menorah pikud & bakara
* Menorah Pikud & Bakara specializes in the design, development, and production of command and control systems of electrical systems, lighting systems, and traffic lights. * Areas of personal responsibility and contribution: * Leading the company in the process of obtaining ISO 9001 certification * Development and implementation of quality policies and procedures * Personnel training * Purchasing and suppliers’ qualification, evaluation and audits * Development and implementation of corrective action plans (CAPA) * Customer complaints handling * Third party audits, including ISO and customer audits

director of quality assurance
vomaris innovations, inc.

director of operations
vomaris innovations, inc.
* Vomaris Innovations Inc. is a medical device company focused in the area of regenerative medicine. The company specializes in bioelectrical field generating technologies for the advanced wound care market. * Areas of personal responsibility and contribution: * Production planning and execution * Resource allocation and management (materials, equipment, facilities, etc) * Suppliers and subcontractors management * Process development and improvement
Education
ort braude college
academia de studii economice din bucurești
business administration
lumi skiba's Contact Information
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