Ardalan K Email
Medical Certification Project Manager @ Modernizing Medicine® Gastroenterology, formerly gMed®
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Ardalan K Location
- Bothell, Washington, United States
Ardalan K Work
- Medical Certification Project Manager @ (May 2015 - Present)
- Certification Project Manager and Lead Auditor @ (December 2014 - Present)
- External Auditor @ (February 2013 - April 2014)
- Lead Auditor @ (March 2009 - March 2014)
- Management Representative and Head of Quality Management Department Regulatory Affair @ Piyatech sdn.bhd (October 2011 - February 2014)
- Medical Devices Lead Auditor @ Aja Iran (January 2007 - January 2012)
- President @ Global Management Pioneers (June 2008 - March 2009)
- Lead Auditor and Instructor @ (January 2001 - January 2008)
- Business Development Manager @ (March 2000 - January 2007)
- Presenter @ Ica Conference (January 2005 - January 2005)
- Methods Engineering Department Manager @ Supa Medical Devices (January 1997 - January 2000)
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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