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Edwin Lopez Email & Phone Number
Senior Regulatory Affairs Specialist
at
Medtronic
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✓ Verified July 2026
3 data sources
Profile completeness 86%
Current company
Role
Senior Regulatory Affairs Specialist
Location
Tijuana, Baja California, Mexico
Company size
Who is Edwin Lopez? Overview
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Quick answer
Edwin Lopez is listed as Senior Regulatory Affairs Specialist at Medtronic, a with 97718 employees, based in Tijuana, Baja California, Mexico. AeroLeads shows a matched LinkedIn profile for Edwin Lopez.
Edwin Lopez previously worked as Quality Specialist at Baxter International Inc. and Regulatory Affairs Specialist at Baxter International Inc.. Edwin Lopez holds Biochemical Engineer, Industrial Biotechnology from Instituto Tecnológico De Tijuana.
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Medtronic
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Profile bio
About Edwin Lopez
Ingeniero Bioquímica con Especialidad en Biotecnología Industrial. Tengo 5 años de experiencia en investigación química. Tengo una afinidad por los procesos de control y estadística, con conocimiento de minitab y autocad. También tengo conocimiento de sistemas de calidad, ingeniería de calidad, estudios de tiempo y movimiento, balance de carriles, ciclos de mejora DMAIC, diagramas de flujo, mediciones de tiempo de método (bimanual, gráficos de operación y ruta) y Six Sigma.
Current workplace
Edwin Lopez's current company
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Medtronic
10 roles
Edwin Lopez work experience
A career timeline built from the work history available for this profile.
Quality Specialist
Regulatory Affairs Specialist
Senior Quality Assurance Analyst
- Subject Matter Expert of the Complaint Handling process.- CAPA Owner, Document change originator and analyst.- Governance of the post market surveillance metrics.-Lead of the integration projects for the Baxter's quality system (complaint handling) after Hillrom was acquired.- Project manager across legacy Hillrom business units for complaint handling process harmonization.-Support in external audit as SME.-Internal auditor, audit readiness and compliance.
Apr 2022 - Apr 2024
Quality Specialist
- Reviewer of the complaint handling process with other QMS elements, such as: doc control, CAPA and Internal Audits.- CAPA/NCR handling related to the complaint handling process.- Project manager for cross-functional teams during complaint process improvements: post market surveillance, adverse event reporting, customer care, risk management, device manufacturing and R & D.- Document control and document changes for Complaint Handling.- Complaint quality review.- Support the complaint process integration when new products and companies are bought by Hillrom.- Coordinating the backroom for ISO/MDSAP/Customer/Corporate audits.- Internal auditor.
May 2021 - Apr 2024
Global Qa Process Specialist / Associate Specialist Qa/Ra
- Coordinate Measure, Analysis, and Improvement elements. - Project manager for product manufacturing improvements based on PMS and customer feedback. Multidisciplinary involvement with Post Market Surveillance QA engineering, suppliers, sustaining engineering, risk management and R&D.- Analysis and review of quality data trending: Complaints trend and CPM’s, NCMRs, CAPAs, Supplier PPMs, First Pass Yield. - Member of the Complaint Review Board and Corrective Action Board. - Internal auditor.- Attend and respond external audit as SME and system navigator (customer audits, ISO 13485 and MDSAP re-certification and surveillance audits).-Support general revisions of product registrations in MDSAP countries.
Dec 2019 - May 2021
Learning Management System Administrator
- Transactional transference projects- QMS Procedures Periodic review.- Doc Changes (from Initiate to Implementation)- Systems access control. (Agile, SAP, Trackwise, etc).- LMS platform tech support.- Training evaluation and assignment for indirect labor.- Collaborations on training process improvement.
Oct 2018 - Nov 2019
Jan 2018 - Jan 2019
Quality Control Chemist / Lab Supervisor
High Performance Liquid Cromatography Assay Performance. Laboratory assays continous improvement. Lab Enviromental and Health Safety. SOPs emission, upgrade and inspection based on national and international standards and regulations. ISO 17025 basis.Continues Improvement, Quality Engineering and Lean manufacturing.
Jan 2018 - Aug 2018
Npi Project
Comercializadora Roxher
Food Industry - New products development project. DOE and Sensorial Evaluation. Market acceptence and introduction.Production protocols based on national regulation.
Aug 2017 - Jan 2018
Team & coworkers
Colleagues at Medtronic
Other employees you can reach at medtronic.com. View company contacts for 97718 employees →
DF
Dawn Field, Pmp
Colleague at MedtronicSimi Valley, California, United States
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FB
Francesca Bozzo
Colleague at MedtronicRome, Latium, Italy
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SR
Sujith Rana
Colleague at MedtronicHyderabad, Telangana, India
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KA
Kimberly Adams (Brant)
Colleague at MedtronicSanta Rosa, California, United States
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PJ
Patty Jin
Colleague at MedtronicShanghai, China
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MM
Mildred Morales
Colleague at MedtronicToa Baja, Puerto Rico
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RK
Rachel Kiekow
Colleague at MedtronicFort Myers, Florida, United States
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WG
Wendy Griffin
Colleague at MedtronicUnited Kingdom
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NA
Nguyen Anh Dung
Colleague at MedtronicVietnam, Viet Nam
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JP
Junaid Parker
Colleague at MedtronicCity Of Johannesburg, Gauteng, South Africa
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Dawn Field, Pmp
Colleague at MedtronicSimi Valley, California, United States
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FB
Francesca Bozzo
Colleague at MedtronicRome, Latium, Italy
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SR
Sujith Rana
Colleague at MedtronicHyderabad, Telangana, India
View →
KA
Kimberly Adams (Brant)
Colleague at MedtronicSanta Rosa, California, United States
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PJ
Patty Jin
Colleague at MedtronicShanghai, China
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MM
Mildred Morales
Colleague at MedtronicToa Baja, Puerto Rico
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RK
Rachel Kiekow
Colleague at MedtronicFort Myers, Florida, United States
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WG
Wendy Griffin
Colleague at MedtronicUnited Kingdom
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NA
Nguyen Anh Dung
Colleague at MedtronicVietnam, Viet Nam
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JP
Junaid Parker
Colleague at MedtronicCity Of Johannesburg, Gauteng, South Africa
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2 education records
Edwin Lopez education
Biochemical Engineer, Industrial Biotechnology
Master'S Degree, Technology Project Management And Design
FAQ
Frequently asked questions about Edwin Lopez
Quick answers generated from the profile data available on this page.
What company does Edwin Lopez work for?
Edwin Lopez works for Medtronic.
What is Edwin Lopez's role at Medtronic?
Edwin Lopez is listed as Senior Regulatory Affairs Specialist at Medtronic.
Where is Edwin Lopez based?
Edwin Lopez is based in Tijuana, Baja California, Mexico while working with Medtronic.
What companies has Edwin Lopez worked for?
Edwin Lopez has worked for Medtronic, Baxter International Inc., Universidad Tecnológica De Tijuana, Sbl Pharmaceutical S De Rl De Cv, and Comercializadora Roxher.
Who are Edwin Lopez's colleagues at Medtronic?
Edwin Lopez's colleagues at Medtronic include Dawn Field, Pmp, Francesca Bozzo, Sujith Rana, Kimberly Adams (Brant), and Patty Jin.
How can I contact Edwin Lopez?
You can use AeroLeads to view verified contact signals for Edwin Lopez at Medtronic, including work email, phone, and LinkedIn data when available.
What schools did Edwin Lopez attend?
Edwin Lopez holds Biochemical Engineer, Industrial Biotechnology from Instituto Tecnológico De Tijuana.
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