Adam Hoopai
Director, Quality Assurance at Abbott
- Role
- Director of Quality Assurance at Abbott
- Location
- Mountain View, CA, US
- LinkedIn followers
- 500 followers
About Adam Hoopai
CAPA: Experienced with Root Cause Analysis (RCA)Quality Systems ExperienceMfg. Site Physician EducationFDA, DEKRA, Medcert Audit ExperienceInjection Molded ComponentsManufacturing Management: Lean manufacturing, Utilization (equipment and personnel), Build Scheduling/CoordinationProcess Development (coronary devices): includes drug coating development for metallic and bioresorbable technologies. combination drug/device regulations.Validation/Verification: Process Qualification, Verification and ValidationEquipment QualificationExperienced with 21 CFR Part 210/211/820, ISO13485, ISO11607, ISO25539 Experience with Submissions to Notified bodies (FDA, Medcert, Health Canada, PMDA, SFDA, MFDS)Sterilization Technologies and Strategy (Radiation and EthyleneOxide)Specialties: Project lead (planning, execution and budget management)Specification SettingProcess Development (Design of Experiment, Critical Process Parameters, etc.)Process ValidationNon-Normal Data Analysis (Truncated Data, Negative Binomial, Cpk\'s, etc.)Coating DevelopmentRoot Cause AnalysisEquipment/Process QualificationOperations Management (Lean Manufacturing concepts and implementation, metrics)
Experience
Director of Quality Assurance
Aug 2023 — Present · San Francisco, CA, US
Education
UC San Diego
B.S., Chemical Engineering
2001 — 2005
Riverside Poly High School
High School Diploma, High School
1997 — 2001
Skills
- Jmp
- Negotiation
- Fda
- Operations Management
- Medical Devices
- Capa
- Mediation
- Design Control
- Root Cause Analysis
- R&D
- Targeted Selection Interviewing
- Project Management
- Change Management
- Specifications
- Validation
- Iso 13485
- Lean Manufacturing
- Risk Management
- Cpk
- Design of Experiments
- Manufacturing
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