Iris Luna

Director, Quality Compliance @Integra LifeSciences

Irvine, CA, US
MOBILE NUMBERS
+19•••••••03

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WORK HISTORY

Dec 2024 — Present

Director, Quality Compliance @Integra LifeSciences

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EDUCATION

1996 — 2000

Instituto Tecnológico de Santo Domingo

Bachelor of Engineering (B.E.), Industrial Engineering

2002 — 2004

Universitat Politècnica de Catalunya

Master's degree, Business Administration, Management and Operations

SKILLS

Medical DevicesCapaIso 9000OutlookInternal AuditQuality ControlLean ManufacturingFmeaCorrective ActionsEmployee TrainingSupplier QualityWindowsCorrective and Preventive Action (Capa)Problem SolvingIsoBusiness Process ImprovementFdaContinuous ImprovementTrain the Trainer CertifiedTeachingQuality SystemSix SigmaQuality AuditingIso 13485Iso 9001Microsoft WordProject ManagementProcess ImprovementEnglishRoot Cause AnalysisDmaicSpcMicrosoft OfficeMicrosoft ExcelPowerpoint

ABOUT IRIS LUNA

Accomplished Industrial Engineer with over 20 years of experience including supplier evaluation, corrective and preventive actions, complaints, nonconformances, internal audits, external audits, quality operations, quality engineering, control of records, control of documents, calibrations, new product introduction, validations, risk management, recalls, microbiology lab, field corrective actions and management review.Well versed in medical device industry and regulations.Fluent in both English and Spanish.I am known for my strong multitasking skill and my focus to results, relentlessly pursuing and reaching multiple goals. I am oriented to high standards and continuous improvement. Personality Preference: ISTJI am energized from my internal world of ideas and impressions. Decision making is based in my experience and knowledge of the facts, in a logical framework.Core Strenghts (StrenghtsFinder 2.0)Strategic: I\'m talented creating alternative ways to proceed. Faced with any given scenario, I can quickly spot the relevant patterns and issues.Learner: I\'m very excited by the process of learning. I dedicate time to read and acquire new knowledge.Achiever: I work hard and feel great satisfaction from being busy and productive. I delight in juggling multiple tasks at the same time.Input: I enjoy collecting information. Reading about topics that interest or fascinate me is an important factor of my quality of life equation.Responsibility: I\'m eager to fulfill my commitments. I\'m very accountable and feel good when keeping my promises.

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