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Frank Halik Location
United States
Frank Halik Work
Senior Director of Product and Design Assurance @ (March 2024 - Present)
Senior Director Quality @ (August 2023 - December 2023)
Director Of Quality @ (February 2015 - April 2022)
Senior Manager of Supply Chain Quality and Configuration @ (November 2013 - February 2015)
QUALITY ENGINEERING MANAGER @ (April 2008 - November 2013)
Principal and Founder @ (April 2022 - October 2024)
Process Engineer @ Roche Diagnostics (January 1998 - January 2008)
Frank Halik Education
Purdue University - Office of the Vice Provost for Graduate Students and Postdoctoral Scholars
Masters (Biotechnology Innovation and Regulatory Science)
2016-2021
Indiana University Indianapolis
Bachelor of Science - BS (Electrical Engineering Technologies/Technicians)
2004-2004
Frank Halik Skills
FDA
Process Validation
Validation
Medical Devices
Quality Systems
MES
Continuous Improvement
Manufacturing
SAP
Automation
Process Engineering
Quality Assurance
Quality System
Supply Chain Management
GAMP
Process Improvement
GMP
ISO 13485
V&V
Six Sigma
CAPA
Lean Manufacturing
21 CFR Part 11
Sop
Cross-functional Team Leadership
Design Control
Production Planning
Root Cause Analysis
Design of Experiments
FMEA
Process Simulation
Computer System Validation
ISO
Minitab
Technology Transfer
Change Control
Biotechnology
Quality Management
5S
Quality Control
Leadership
Marketing
Cross Functional Team Leadership
SQL
Management
Project Management
Verification And Validation V&V
U.S. Food And Drug Administration Fda
Business Process Improvement
ISO Standards
u.s. Food and Drug Administration
Verification and Validation
Frank Halik Summary
Frank Halik, based in United States, is currently a Senior Director of Product and Design Assurance at HistoSonics, Inc.. Frank Halik brings experience from previous roles at Fellow and Roche Diagnostics. Frank Halik holds a 2016 - 2021 Masters in Biotechnology Innovation and Regulatory Science @ Purdue University - Office of the Vice Provost for Graduate Students and Postdoctoral Scholars. With a robust skill set that includes FDA, Process Validation, Validation, Medical Devices, Quality Systems and more. Frank Halik has 1 emails and 7 mobile phone numbers on RocketReach.
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