Eduardo Blanco
Vice President Quality Assurance and Regulatory Compliance at Breg
- Role
- Vice President Quality Assurance and Regulatory Compliance at Breg
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Eduardo Blanco
An effective, results-oriented leader with a passion for motivating and mentoring individuals and leading teams to support the growth and success of medical device companies. Proven expertise with Class I, II and medical devices and: 21 CFR Part 820; ISO 13485:2003; Design Controls; Risk Management; Process Validation; Six Sigma, Design for Six Sigma and TQM; Design of Experiments and Statistical Techniques such as hypothesis testing, probability theory and SPC; CMDR and AATB regulations; due diligence and integration projects, product transfers, strategic planning and P&L management.
Experience
Vice President Quality Assurance and Regulatory Compliance
Nov 2019 — Present · San Diego, CA, US
Skills
- Minitab
- Cqa
- Fda Gmp
- Six Sigma
- Quality Auditing
- Design of Experiments
- Manufacturing
- Cross-Functional Team Leadership
- Supplier Quality
- Iso 14971
- Quality Control
- Gmp
- Quality System
- V&V
- Statistics
- 21 Cfr Part 11
- Iso 13485
- Ce Marking
- Dmaic
- Operational Due Diligence
- Design Control
- Medical Devices
- Capa
- Product Development
- P&L Management
- Root Cause Analysis
- Root Cause Problem Solving
- Design Conrols
- Process Improvement
- Project Management
- Change Control
- Fda
- Spc
- Proces Validation
- Collaborative Leadership
- Medical Device Directive
- Validation
- 21 Cfr
- Sterilization
- Strategic Planning
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