Quality Assurance Specialist - Regulatory
Current
Jul 2022 - Present
AeroLeads people directory · profile
Karla Cordero Email & Phone Number
Quality Assurance - Regulatory Affairs Specialist
at
Omega Bio-tek
LinkedIn matched
✓ Verified May 2026
3 data sources
Profile completeness 100%
Current company
Role
Quality Assurance - Regulatory Affairs Specialist
Location
Alpharetta, Georgia, United States
Company size
Who is Karla Cordero? Overview
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Quick answer
Karla Cordero is listed as Quality Assurance - Regulatory Affairs Specialist at Omega Bio-tek, a company with 54 employees, based in Alpharetta, Georgia, United States. AeroLeads shows a matched LinkedIn profile for Karla Cordero.
Karla Cordero previously worked as Quality Assurance Specialist - Regulatory at Omega Bio-Tek and Quality and Continuous Improvement Technician at Ortoalresa. Karla Cordero holds Yellow Belt, Lean Six Sigma, 94/100 from Lean Six Sigma Institute Llc.
Company email context
Email format at Omega Bio-tek
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Omega Bio-tek
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Profile bio
About Karla Cordero
Industrial Engineer, MBA for Industrial Companies. Logistics and Supply Chain specialist. Certified ISO 9001 Internal Auditor. Quality System implementation following ISO 13485. Experience in European Regulations (EU) 2017/745 - (EU) 2017/746, European Medical Device Directives (93/42/EEC - 98/79/EEC) and medical device certification process (Technical File, Device Testing). Optimising Business Processes to ensure regulations compliance, increase customer satisfaction and reduce product cost.
Listed skills include Tibco Business Studio, Bizagi, Autocad, Crm, and 38 others.
Current workplace
Karla Cordero's current company
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Omega Bio-Tek
5 roles
Karla Cordero work experience
A career timeline built from the work history available for this profile.
Quality And Continuous Improvement Technician
Design, development, documentation management and technical assistance of the manufactured products (IVD and General use) as well as the management and maintenance of the quality system implemented in Ortoalresa (ISO 9001 and ISO 13485). European Medical Devices Regulatory Specialist (EU) 2017/745 and (EU) 2017/746.
Apr 2019 - Nov 2021
Project Management Specialist
Project analysis and process definition in search of the highest quality and optimization. Identifying project risks and doubts.Development of appropriate documentation to inform and communicate throughout the project.Get information flow between different areas unifying processes under a common project.Planning and monitoring of deadlines as a control.
Sep 2012 - Sep 2013
Support Process Engineer
- Ensure the smooth functioning of business processes and compliance controls. - Processes documentation. - Ensuring awareness of the processes in the different groups of interests of the company
Jan 2009 - Nov 2011
System & Process Assurance
- Financial and operation applications/business process controls reviews- Database security controls reviews- IT general controls reviews- Infrastructure security reviews- Third party assurance and opinion services- Sarbanes-Oxley readiness, process improvement and sustainability services- Compliance with other regulatory requirements (e.g., Turnbull.
Oct 2006 - Oct 2008
Team & coworkers
Colleagues at Omega Bio-tek
Other employees you can reach at omegabiotek.com. View company contacts for 54 employees →
TC
Tyra Clifford
Colleague at Omega Bio-Tek
Atlanta, Georgia, United States, United States
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SW
Spencer White
Colleague at Omega Bio-Tek
Grayson, Georgia, United States, United States
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MK
Merlin Kiruba
Colleague at Omega Bio-Tek
Chennai, Tamil Nadu, India, India
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ÁS
Ángel Silva Peña
Colleague at Omega Bio-Tek
Madrid, Community Of Madrid, Spain, Spain
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JR
Jeff Roeder
Colleague at Omega Bio-Tek
Norcross, Georgia, United States, United States
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TM
Tina Moore
Colleague at Omega Bio-Tek
Atlanta Metropolitan Area, United States
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AS
Arif Syed
Colleague at Omega Bio-Tek
Mumbai, Maharashtra, India, India
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JL
Jonatan Lysen
Colleague at Omega Bio-Tek
Atlanta, Georgia, United States, United States
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SL
Stella Lee
Colleague at Omega Bio-Tek
Norcross, Georgia, United States, United States
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AN
Ahmad Nabiyar
Colleague at Omega Bio-Tek
Denver Metropolitan Area, United States
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Tyra Clifford
Colleague at Omega Bio-Tek
Atlanta, Georgia, United States, United States
View →
SW
Spencer White
Colleague at Omega Bio-Tek
Grayson, Georgia, United States, United States
View →
MK
Merlin Kiruba
Colleague at Omega Bio-Tek
Chennai, Tamil Nadu, India, India
View →
ÁS
Ángel Silva Peña
Colleague at Omega Bio-Tek
Madrid, Community Of Madrid, Spain, Spain
View →
JR
Jeff Roeder
Colleague at Omega Bio-Tek
Norcross, Georgia, United States, United States
View →
TM
Tina Moore
Colleague at Omega Bio-Tek
Atlanta Metropolitan Area, United States
View →
AS
Arif Syed
Colleague at Omega Bio-Tek
Mumbai, Maharashtra, India, India
View →
JL
Jonatan Lysen
Colleague at Omega Bio-Tek
Atlanta, Georgia, United States, United States
View →
SL
Stella Lee
Colleague at Omega Bio-Tek
Norcross, Georgia, United States, United States
View →
AN
Ahmad Nabiyar
Colleague at Omega Bio-Tek
Denver Metropolitan Area, United States
View →
7 education records
Karla Cordero education
Yellow Belt, Lean Six Sigma, 94/100
Lean Six Sigma Institute Llc
Master'S Degree, Gestión De Empresas Tecnológicas E Industriales
Master Logistics And Supply Chain Management, Bussines Process Management
Engineer'S Degree, Industrial Engineering
Specialist, Production And Planning Control, Curso De 3 Meses
Specialist, Facility Layout And Design, Curso De 3 Meses
Bachelor Of Technology (B.Tech.), Electronics
Instituto Técnico Salesiano (Itesa)
FAQ
Frequently asked questions about Karla Cordero
Quick answers generated from the profile data available on this page.
What company does Karla Cordero work for?
Karla Cordero works for Omega Bio-tek.
What is Karla Cordero's role at Omega Bio-tek?
Karla Cordero is listed as Quality Assurance - Regulatory Affairs Specialist at Omega Bio-tek.
Where is Karla Cordero based?
Karla Cordero is based in Alpharetta, Georgia, United States while working with Omega Bio-tek.
What companies has Karla Cordero worked for?
Karla Cordero has worked for Omega Bio-Tek, Ortoalresa, Grupo Docout, Wind Telecom S.A., and Pwc.
Who are Karla Cordero's colleagues at Omega Bio-tek?
Karla Cordero's colleagues at Omega Bio-tek include Tyra Clifford, Spencer White, Merlin Kiruba, Ángel Silva Peña, and Jeff Roeder.
How can I contact Karla Cordero?
You can use AeroLeads to view verified contact signals for Karla Cordero at Omega Bio-tek, including work email, phone, and LinkedIn data when available.
What schools did Karla Cordero attend?
Karla Cordero holds Yellow Belt, Lean Six Sigma, 94/100 from Lean Six Sigma Institute Llc.
What skills is Karla Cordero known for?
Karla Cordero is listed with skills including Tibco Business Studio, Bizagi, Autocad, Crm, Factorycad, Microsoft Office, Solidworks, and Minitab.
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