Gloriana Alvarez
Quality Assurance Engineer @Trividia Health, Inc
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WORK HISTORY
Quality Assurance Engineer @Trividia Health, Inc
Experienced in FDA CFR 820, ISO 13485, ISO 14971, EU MDD/IVDR regulations for Class I, Class II, and In-Vitro Diagnostics (IVD) medical devices- Trained in supporting design validation and changes through testing, document updates, reviews, and validation efforts- Proficient in document and record management, encompassing generation, approval, change control, and retention (Good Documentation Practices, GDP)- Adept at supporting supplier change requests and corrective/preventive actions, including technical report creation, first article inspections, and supplier collaboration for non-conforming events and continuous improvement- Experienced in UDI implementation, adhering to GS1 specifications, including specification creation, test methods, and training- Proficient in equipment, product, and process validation, including commercial off-the-shelf (COTS) software. Skilled in validation planning, protocol development, execution, review, approval, and reporting. Expertise in test method validation (attribute and variable), MSA, Gage Repeatability & Reproducibility (GR & R), ANOVA, and production process validation (IQ, OQ, PQ), along with sampling plan design, normality testing, and Cpk calculation using Minitab- Experienced in inspection and acceptance testing, covering procedure development, inspector training, and continuous improvement. Familiar with sampling procedures for attribute inspection based on ANSI/ASQ Z1.4-2003 (R2013)- Practiced in owning nonconforming events, material, and product investigations, as well as leading corrective/preventive action (CAPA) efforts, employing systematic problem-solving and root cause analysis techniques.
EDUCATION
Tecnológico de Costa Rica
Bachelor’s Degree, Biotechnology
BioTeknica
Training and Workshop, Design Controls
Tecnológico de Costa Rica
Specialist, Quality Control in Medical Devices Manufacturing
ABOUT GLORIANA ALVAREZ
Data-based, quality-oriented, and risk-driven biotechnology engineer with over 15 years…
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