Jim Ecklein Email & Phone Number
Director, Quality and Regulatory @ Xylem Company
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Jim Ecklein Location
- Saint Paul, MN, US
Jim Ecklein Work
- 2016 -now Director, Quality and Regulatory @
- 2015 -2016 Client Manager and Medical Device Assessor @
- 2010 -2015 International Director of Quality @ Diagnostic Group DGS - A Division of William Demant
- 2005 -2010 Director RA and QA @ Augustine Biomedical + Design
- 2004 -2005 Medical Device Assessor @
- 2002 -2004 Quality System Engineer @ Hutchinson Technology Biomeasurement Division
- 2001 -2002 Director of Quality @ Abbeymoor Medical
- 1997 -2001 Vice President @ The Ryhn Group
- 1988 -1997 Director of Quality @ Augustine Medical
Jim Ecklein Education
- RHS
Jim Ecklein Skills
- Quality Systems
- ISO 13485
- FDA
- Medical Devices
- QSR
- CAPA
- Manufacturing
- Design Control
- Process Validation
- Continuous Improvement
- Manufacturing Management
- Process Improvement
- Quality Auditing
- Team Building
- Process Development
- Cross-functional Team Leadership
- Customer Relations
- Strategic Planning
- Root Cause Analysis
- International Registrations
- Pre-market submissions (510k, Tech Files)
- Quality System
- 21 CFR
- ISO 14971
- SPC
- Calibration
- V&V
- Design of Experiments
- U.S. Food and Drug Administration (FDA)
- Corrective and Preventive Action (CAPA)
- Statistical Process Control (SPC)
- Tech Files
- Mdsap
- Statistical Process Control Spc
- Corrective and Preventive Action Capa
- Cross Functional Team Leadership
- u.s. Food and Drug Administration Fda
- Pre Market Submissions 510k
- Quality Management
- Regulatory Affairs
- Validation
- Quality Assurance
- Medical Device Directive
- Microsoft Office
- Good Manufacturing Practice Gmp
- Failure Mode And Effects Analysis Fmea
- Product Development
- Project Management
- Product Launch
- ISO Standards
- u.s. Food and Drug Administration
- Corrective and Preventive Action
- Statistical Process Control
- Pre Market Submissions
- Failure Mode and Effects Analysis
- Good Manufacturing Practice
Jim Ecklein Summary
- Jim Ecklein, based in Saint Paul, MN, US, is currently a Director, Quality and Regulatory at Xylem Company. Jim Ecklein brings experience from previous roles at BSI, Diagnostic Group DGS - A Division of William Demant and Augustine Biomedical + Design. Jim Ecklein holds a RHS. With a robust skill set that includes Quality Systems, ISO 13485, FDA, Medical Devices, QSR and more. Jim Ecklein has 2 emails and 1 mobile phone numbers on RocketReach.
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