Gheorghi Opatchi
Director | Quality Management | Positive Psychology Advocate | Angel Investor | Founder
- Role
- Director of Quality at Dna Electronics Dnae
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Gheorghi Opatchi
Global Quality & Regulatory Leader | ISO 13485 | FDA 21 CFR Part 820 | MDSAP | IVDRI help medical device and biotech companies navigate complex international standards and regulations. My work focuses on building management systems that go beyond compliance to accelerate innovation and enable sustainable growth. Leadership & Compliance ExcellenceI’ve led cross-functional teams across multiple regions to achieve compliance with ISO 13485, FDA 21 CFR Part 820, MDSAP, and IVDR. I’m known for creating alignment between quality, operations, and business goals — ensuring compliance becomes a foundation for performance, not a barrier to it. Transformational ImpactI’ve successfully managed global ISO transition programs and regulatory initiatives that opened new market opportunities, supported clinical expansion, and improved organizational efficiency. My approach blends strategic vision with hands-on execution to deliver measurable results. Core Expertise- Quality & regulatory program leadership- Organizational performance and team development- Process design, auditing, and continuous improvement- Lean systems and operational excellence- Strategic planning and problem-solving in global environments Passion & PurposeI’m passionate about helping organizations excel in compliance, streamline operations, and build resilient, lean systems that protect patients and strengthen long-term success.
Experience
Director of Quality
Feb 2023 — Present · Carlsbad, CA, US
Education
Université de Technologie de Compiègne (UTC)
Master’s Degree, Quality and Performance Management
UC San Diego Extended Studies
Business Management Program, Strategic Management
University POLITEHNICA of Bucharest
Engineering Degree, Industrial Engineering Management
Skills
- Key Performance Indicators
- Project Management
- Fda 21cfr Part820
- Continuous Improvement
- Quality System Improvement
- Iso 13485
- Conformity Assessment
- Deamrche D'optimisation
- Capa
- Ingénieur Qualité
- Quality Assurance
- Increasing Operational Efficiency
- Autodiagnostic Qualite
- Quality Management
- Iso 19011
- Quality Auditing
- Lean Thinking
- Process Optimization
- Amdec
- Lean Tools
- Internal Audit
- Performance Improvement
- Iso 9001
- Lean Management
- Iso 14971
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