2019 -now Director of Regulatory and Quality Affairs @
2017 -2019 QA and RA Manager (Contract) @ AirStrip Technologies
2009 -2017 Regulatory Affairs and Compliance Manager @
2003 -2009 QA and Regulatory Affairs Manager @
1994 -2003 QC and QA Manager @
1979 -1994 Technologist, Scientist, Product Group Supervisor @
Kirk Johnson Education
St Mary's University
(Biology, Chemistry)
1975-1979
Kirk Johnson Skills
UV
Design Control
Regulatory Requirements
Computerized System Validation (CSV)
Quality Control
Quality Auditing
Regulatory Advice
Medical Device Regulation (MDR)
GMP
Medical Devices
FDA
CAPA
Regulatory Affairs
Biotechnology
ISO 14971
Validation
Regulatory Submissions
CE marking
ISO 13485
Verification and Validation (V&V)
Kirk Johnson Summary
Kirk Johnson, based in Houston, TX, US, is currently a Director of Regulatory and Quality Affairs at Medical Metrics, Inc.. Kirk Johnson brings experience from previous roles at AirStrip Technologies and Stanbio Laboratory. Kirk Johnson holds a 1975 - 1979 St Mary's University. With a robust skill set that includes UV, Design Control, Regulatory Requirements, Computerized System Validation (CSV), Quality Control and more. Kirk Johnson has 3 emails and 1 mobile phone numbers on RocketReach.
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