lumi skiba

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.

Country

united states

City

tempe

Industry

medical devices

Skill

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

t.a.g medical

quality assurance manager

t.a.g medical

2001-2 - 2004-10 · 3 yrs 9 mos
precise medical products pmp

quality assurance manager

precise medical products pmp

1999-4 - 2001-2 · 1 yr 11 mos
menorah pikud & bakara

quality assurance manager

menorah pikud & bakara

1996-3 - 1998-5 · 2 yrs 3 mos

* 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

vomaris innovations, inc.

director of quality assurance

vomaris innovations, inc.

2005-9 - 2015-7 · 9 yrs 11 mos
vomaris innovations, inc.

director of operations

vomaris innovations, inc.

2015-7 - Present · 11 yrs 3 mos

* 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

ort braude college

1992-1 - 1995-1 · 3 yrs 1 mo
academia de studii economice din bucurești

academia de studii economice din bucurești

business administration

1988-1 - 1991-1 · 3 yrs 1 mo

lumi skiba's Contact Information

Email

******@***.com

Phone

(**) *** ****

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