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Ardalan K Location
Bothell, Washington, United States
Ardalan K Work
2015 -now Medical Certification Project Manager @
2014 -now Certification Project Manager and Lead Auditor @
2013 -2014 External Auditor @
2009 -2014 Lead Auditor @
2011 -2014 Management Representative and Head of Quality Management Department Regulatory Affair @ Piyatech sdn.bhd
2007 -2012 Medical Devices Lead Auditor @ Aja Iran
2008 -2009 President @ Global Management Pioneers
2001 -2008 Lead Auditor and Instructor @
2000 -2007 Business Development Manager @
2005 -2005 Presenter @ Ica Conference
1997 -2000 Methods Engineering Department Manager @ Supa Medical Devices
Ardalan K Education
University of Tehran
Bachelors (Industrial Engineering)
1992-1996
Ardalan K Skills
Manufacturing Process Improvement
Engineering
Quality Management
Quality System
ISO 13485
Medical Devices
ISO
Quality Auditing
Manufacturing
Quality Assurance
Auditing
Project Management
Product Development
Risk Management
Business Planning
Six Sigma
Continuous Improvement
Business Process Improvement
Process Engineering
Inspection
FMEA
Lean Manufacturing
Regulatory Affairs
Internal Audit
Technical Documentation
Supply Chain Management
Business Process Mapping
CRM
Change Control
Business Development
Microsoft Office
Cross-functional Team Leadership
Team Management
Problem Solving
Team Leadership
Team Building
CE marking
ISO 14971
Process Improvement
Medical Device Directive
CMDCAS
Certified Lead Auditor
Product Certification
OHSAS18001
IVD
CMDR
Cross Functional Team Building
Medical Devices Directive (MDD)
MDSAP
MDR
Ardalan K Summary
Ardalan K, based in Bothell, Washington, United States, is currently a Medical Certification Project Manager at Gmed. Ardalan K brings experience from previous roles at Lne/G-Med North America, Inc., Qs Zürich Ag Iso Certification, Atex, Medical Devices in Middle East, SGS and Piyatech sdn.bhd. Ardalan K holds a 1992 - 1996 Bachelors in Industrial Engineering @ University of Tehran. With a robust skill set that includes Manufacturing Process Improvement, Engineering, Quality Management, Quality System, ISO 13485 and more. Ardalan K has 3 emails on RocketReach.
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