Al Crouse
- Role
- Vice President of Regulatory Affairs and Quality Assurance at CVRx | Barostim
- Location
- Minneapolis, MN, US
- LinkedIn followers
- 500 followers
About Al Crouse
More than 30 year of experience in Quality, Reliability, Regulatory, Manufacturing and…
Experience
Vice President of Regulatory Affairs and Quality Assurance
Jan 2023 — Present
Responsible for development and maintenance of the quality system. Responsible for document control, product and process quality, software quality, supplier quality, internal and external audits, calibration, and training. Piloted numerous quality initiatives with FDA and MDIC and currently serving on the Governing Committee for the Medical Device Information and Analysis Sharing (MDIAS) program.
Education
University of Colorado Boulder - Leeds School of Business
MBA, Operations Management/Finance
1988 — 1989
Iowa State University
BS, Electrical Engineering
1978 — 1982
Skills
- Continuous Improvement
- Fda Gmp
- Root Cause Analysis
- Medical Device R&D
- Iso 9000
- V&V
- Validation
- Spc
- Gmp
- R&D
- Manufacturing Engineering
- Iso 13485
- Change Control
- Lean Manufacturing
- Quality Management
- Regulatory Affairs
- Fmea
- Value Stream Mapping
- Capa
- Biomedical Engineering
- 5s
- Fda
- Iso 14971
- Black Belt
- Medical Devices
- Gage R&R
- Design of Experiments
- Gxp
- 21 Cfr
- Design Control
- Manufacturing Operations
- Six Sigma
- Quality System
- Process Capability
- Dmaic
- Quality Auditing
- Iso
- Failure Analysis
- Contract Manufacturing
- Ce Marking
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