Steve Hellstrom Email & Phone Number
Looking for my next opportunity
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Steve Hellstrom Location
- United States
Steve Hellstrom Work
- 2025 - now Looking for my next opportunity @ Open to new VP of Quality roles
- 2022 - 2024 Vice President Of Quality @
- 2019 - 2022 Senior Director FDA Compliance @
- 2015 - 2019 Global Quality Assurance Director @
- 2013 - 2015 Corporate Quality Director, Sterile Procedural Trays Division @
- 2012 - 2013 Principal Consultant @ Microfluidics, LLC
- 2010 - 2012 Director of Quality Systems Engineering @
- 2004 - 2009 Quality Director @
- 1991 - 2004 R and D Director @
- 2001 - 2004 R and D DIrector @
- 1988 - 1993 Development Engineer @
Steve Hellstrom Education
- Northern Illinois University
MBA (Business)
- Michigan State University
BS Eng (Mechanical Engineering)
- West Leyden High School
Steve Hellstrom Skills
- Medical Devices
- Leadership
- Quality System
- FDA Audits
- Clean Rooms
- Critical Thinking
- Engineering Management
- FDA GMP
- Quality Process Development
- Cleanroom Manufacturing
- SDLC
- Pumps
- Cross-functional Team Leadership
- Auditing
- Validation
- FDA
- GMP
- ISO 13485
- R&D
- Design Control
- CAPA
- ISO 14971
- 21 CFR Part 11
- Quality Auditing
- Biomedical Engineering
- Commercialization
- Lean Manufacturing
- Manufacturing
- V&V
- Product Development
- Quality Assurance
- Sop
- Supplier Quality
- Design of Experiments
- Regulatory Affairs
- FMEA
- Pharmaceutical Industry
- Process Improvement
- Testing
- Continuous Improvement
- Quality Management
- Six Sigma
- Strategy
- SPC
- Change Control
- Technology Transfer
- Process Simulation
- ISO
- Root Cause Analysis
- Regulatory Submissions
- Product Launch
- CE marking
- Capital Equipment
- Engineering
- Product Design
- Market Development
- 21 CFR
- Cross Functional Team Leadership
- Japanese
- Integration
- Program Management
- System Integration
- Public Speaking
- Compliance
- Business Analysis
Steve Hellstrom Summary
- Steve Hellstrom, based in United States, is currently a Looking for my next opportunity at Open to new VP of Quality roles. Steve Hellstrom brings experience from previous roles at Flexan, Fresenius Kabi USA, Hollister Incorporated and Medline Industries, Inc.. Steve Hellstrom holds a MBA in Business @ Northern Illinois University. With a robust skill set that includes Medical Devices, Leadership, Quality System, FDA Audits, Clean Rooms and more. Steve Hellstrom has 1 emails and 2 mobile phone numbers on RocketReach.
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Steve Hellstrom
Looking for my next opportunity
United States
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