Procoro Herrera
- Role
- Director of Design Assurance and Regulatory Affairs at Ormco
- Location
- Orange, CA, US
- LinkedIn followers
- 500 followers
About Procoro Herrera
Experienced professional in Quality Engineering, Quality Assurance, and Regulatory…
Experience
Director of Design Assurance and Regulatory Affairs
May 2017 — Present
Lead the regulatory affairs and design assurance functions through all design control, submission, and registration activities. • Provide leadership to team remediating technical files to support new EU MDR requirements. • Provide leadership to team performing clinical evaluation and post-market surveillance reports. • Provide strategy for level of substantiation necessary for marketing literature approval. • Successfully managed multiple technical file, microbiological assessment, and MDSAP audits. • Subject matter expert for design and software verifications, risk management, software validations, process validation, and statistical rationale for sampling plans.
Education
California State Polytechnic University-Pomona
BS, Industrial Engineering
1989 — 1995
California State University-Dominguez Hills
MS, Quality Assurance
2001 — 2004
Skills
- Iso 13485
- Lean Manufacturing
- Quality Assurance
- Kaizen
- Regulatory Affairs
- Value Stream Mapping
- Manufacturing Engineering
- Validation
- Quality Auditing
- V&V
- 5s
- Capa
- Design of Experiments
- Process Engineering
- Quality Control
- Six Sigma
- Manufacturing Operations
- Fda
- Quality Management
- R&D
- Cross-Functional Team Leadership
- Spc
- Medical Devices
- Continuous Improvement
- Fmea
- Design Control
- Testing
- Iso
- Root Cause Analysis
- Gmp
- Product Development
- Quality System
- Manufacturing
- Fda Gmp
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