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Frank Halik Location
United States
Frank Halik Work
2024 -now Senior Director of Product and Design Assurance @
2022 -2024 Principal and Founder @
2023 -2023 Senior Director Quality @
2015 -2022 Director Of Quality @
2013 -2015 Senior Manager of Supply Chain Quality and Configuration @
2008 -2013 QUALITY ENGINEERING MANAGER @
1998 -2008 Process Engineer @ Roche Diagnostics
Frank Halik Education
Purdue University - The Graduate School (In Progress) 2016-2021
Indiana University Indianapolis 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 OnQ Performance Consulting, Fellow and Roche Diagnostics. Frank Halik holds a 2016 - 2021 Purdue University - The Graduate School (In Progress). 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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