Steve Hellstrom

Vice President of Quality at Flexan

Based in United States

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Seniority

Vp

Department

General Business & Management

Location

United States

Industry

Medical Equipment Manufacturing

Company size

170

Contact information

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Email

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s•••••••@flexan.com

Phone

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Background

About Steve Hellstrom

Medical Device leader with experience in a broad array of medical devices and scientific products. Experience in New Product Development, Quality Systems, and process development for Medical Devices for compliance to US, European, and Japanese markets. NPDP- Certified New Product Development Professional Program Management Product designer with 12 US patents and 2 European patents. Manufacturing Quality and QC Leadership Specialties: New Product Development Quality Systems Design and Development FDA/Notified Body Audits Customer, Internal, and Supplier Audit experience Verification and Validation Reliability Planning Metrics Development Risk Mgmt (ISO 14971) Lean Project Leadership Design Controls Talent Identification and Dev. CAPA Due Diligence European Device Regs (ISO 13485) Post Market Surveillance International Team Leadership Management Reviews Product Recovery and Continuous Improvement Electromechanical and Software Development

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Steve Hellstrom Email & Phone Number @ Flexan | Kipplo Discover