Federico Perez
Director, QM/RA at Ambu (King Systems)
- Role
- Director Qm Ra at Ambu King Systems
- Location
- Westfield, IN, US
- LinkedIn followers
- 500 followers
About Federico Perez
Quality and compliance professional with 16+ years of experience in the FDA regulated industry, primarily focused in quality management system (QMS) remediation, overhaul and integration, project management, and quality engineering of medical devices. Extensive knowledge of FDA (21 CFR), EU MDR and ISO regulations, risk management, statistical methodologies (SPC, ANOVA, DOE, etc.), statistical based sampling, process improvement, and vast experience in the validation of a diverse variety of manufacturing processes, equipment and software for the medical device Industry.
Experience
Director Qm Ra
Oct 2025 — Present · Noblesville, IN, US
Education
Instituto Tecnológico de Santo Domingo
Post Bachelor's in Quality and Productivity Management, Engineering
2005 — 2006
Instituto Tecnológico de Santo Domingo
Industrial Engineer, Engineering
1999 — 2003
Skills
- Computer System Validation
- Iso Standards
- Quality Control
- Iso 13485
- Gmp
- Iso
- Pharmaceutical Industry
- Business Process Improvement
- Verification and Validation (V&V)
- Fda
- Lean Manufacturing
- Root Cause Analysis
- Validation
- Dmaic
- Quality Assurance
- Process Improvement
- Quality System
- V&V
- Process Simulation
- Process Engineering
- Design Control
- Minitab
- Change Control
- Fmea
- Organizational Leadership
- 21 Cfr Part 11
- Spc
- Six Sigma
- Quality Auditing
- Iso 14971
- Medical Devices
- Capa
- Statistical Process Control (Spc)
- U.s. Food and Drug Administration (Fda)
- Design of Experiments
- Manufacturing
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