Daniela Rivero
Quality and Regulatory Affairs Engineer I at Peca Labs- Claim this Profile
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Spanish Native or bilingual proficiency
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Bio
Credentials
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Certified Lead Auditor on ISO 22000:2018
Bureau Veritas GroupAug, 2019- Oct, 2024
Experience
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Peca Labs
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Quality and Regulatory Affairs Engineer I
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Jun 2020 - Present
- Maintain and grow company's ISO 13485 and FDA-Compliant Quality System - Transition paper quality system to digital (Salesforce eQMS) - Develop strategies for regulatory approval and introduction of new products to market - Manage the process from development of regulatory strategies through to approval - Prepare and submit submissions and ensure compliance with all regulatory requirements pertaining to product approvals - Ensure that all regulatory-related policies and procedures are current and in accordance with applicable regulations and standards - Provide regulatory guidance and support to project teams, including regulatory filing strategies, testing and standards requirements - Establish appropriate risk analysis activities, which include the use of risk analysis tools - Provide updates on regulatory requirement changes, which affect individual product specifications or quality systems - Processes RMA’s - Write NCMRs - Worked cross-departmentally to maintain the work flow of the company Show less
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Lactalis Nestle
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Portugal
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Manufacturing
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1 - 100 Employee
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Quality and Production Trainee
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Jun 2019 - Nov 2019
Performed quality controls on product (microbiological, chemical and physical) and participated in trials, development of new products, improvements in composition, processes and introduction of new raw materials in the scope of ISO 22000, ISO9001, ISO14001. - Reviewed technical data sheets of raw materials and products. - Performed factory inspections and measurement of quality and production indicators. - Performed incident management and product traceability to determine what caused quality incidents. - Communicated changes and relevant information of quality and safety to employees and stakeholders. - Managed and reviewed prerequisite program and the HACCP plan. - Calibrated and verified equipment such as PH meter, scale, densimeter, etc. Show less
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Internship Program
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Mar 2019 - May 2019
Internship developed at the Madrid Public Health Laboratory, in different areas. - Treatment of HPLC techniques - PCR technique - Study of fats and alcohols - Dyes and preservatives - Formation of acrylamide - Use of pesticides - Nutritional analysis and presence of heavy metals Internship developed at the Madrid Public Health Laboratory, in different areas. - Treatment of HPLC techniques - PCR technique - Study of fats and alcohols - Dyes and preservatives - Formation of acrylamide - Use of pesticides - Nutritional analysis and presence of heavy metals
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Education
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2018 - 2019
CESIF
Magister in Food Industry, Food Science and Technology -
2012 - 2017
Universidad Metropolitana (VE)
Bachelor's degree, Chemical Engineering
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