KEVIN MAGDIEL BUENROSTRO RAMÍREZ

magdiel2605@gmail.com / (849) 878-5856

Street O #29, Res. Brisa Oriental, San Isidro San Isidro Highway Santo Domingo Este, D.R.

Industrial Engineer: Responsible, organized, leader, innovative, pro-active, analytic, results-

oriented, self-directed, and entrepreneur. Strong proficiency in Regulatory Compliance, Root
Cause Investigation tools and Audit Processes. Passionate of Applied Statistics and Design of
Experiments.

EDUCATION

Industrial Engineering – Instituto Tecnológico de Santo Domingo (INTEC) – 2018

WORK EXPERIENCE
▪ MicroPort CRM – Quality Systems Engineer (April – Dec 2022)
✔ Managed local Change Control Process, ensuring compliance with written procedures,
standards and regulatory requirements.
✔ Assisted in the Review and Approval of local Change Controls as required.
✔ Managed local Training process, ensuring compliance with written procedures,
standards and regulatory requirements.
✔ Participated in the Review and approval of new or modified Training Matrices as
needed.
✔ Ensured the training of all relevant personnel before new or modified procedures
being released/implemented.
✔ Managed local CAPA process, making sure of compliance with established procedures,
standards and regulatory requirements.
✔ Managed the proper storage, maintenance, and retrieval of physical documents, as well
as ensuring its correct organization and classification, according to established
procedures and standards and regulatory requirements.
✔ Overseed local Audit Process, ensuring compliance with written procedures, standards
and regulatory requirements.
✔ Developed Audit Support Plans, checklists and communicate Audit results to all
relevant parties.
✔ Gathered and led the multifunctional team (such as Subject Matter Experts (SMEs),
runners, requestors, and so on) that offered support during the audit, assuring the
proper flow of the evidence and interviews being requested by the auditors.
✔ Performed timely Follow-ups to local Audit Observations.
✔ Led annual Good Manufacturing Practices (GMPs) training for all employees of the
local plant.
✔ Supervised and led technical staff in Training, Change Control and Documentation
areas.
✔ Participated in the Review and approval of new or modified written Procedures as
needed.
✔ Played a key role in process improvement initiatives, and ensuring regulatory
compliance throughout the manufacturing process.
✔ Led or supported Root Cause Investigations and CAPA Plans (including Measurement
of Effectiveness Plan with proper statistical justification) as needed.

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▪ ConvaTec Inc. – Quality Operations Engineer (2021 – 2022)
✔ Ensured all Manufacturing Operations were running according to Quality Standards
and Regulations, as well as written procedures.
✔ Supervised and led all Technical Staff of the Quality Operations Area.
✔ Actively participated in the internal Nonconformities of the Manufacturing Process, as
well as the coordination and decision of the correct disposition of affected Products.
✔ Performed Review and Approval of Nonconformities of the Manufacturing Process.
✔ Performed Creation, Reviewing and Approval of Controlled Documents, regarding the
Manufacturing Process.
✔ Executed Implementation of Improvement Projects in Quality Sampling Plan to enhance
the detection Level of Quality Inspections based on Characteristics Operation Curves,
ANSI Tables, Measurement System Analysis (MSA), etc.

▪ ConvaTec Inc.– Quality Compliance Engineer (2020 – 2021)

✔ Performed Customer Complaints Investigation as required.
✔ Performed Root Cause Investigations as required.
✔ Performed Assessments for Implementation of Corrective / Preventive Actions
(CAPAs) as needed.
✔ Carried out Measurement of CAPA Actions Effectiveness.
✔ Assisted in the Review & Approval of Nonconformance Reports (NCRs).
✔ Executed Trend Analysis of Customer Complaints and Nonconformance Reports Data.

▪ Bbraun Medical Inc. – Quality Assurance (QA) Specialist (2018 – 2020)

✔ Performed Follow-ups to External and Internal Audit Observations.
✔ Supported Investigation of External and Internal Audit Observations.
✔ Performed Control and Registration of Audit Observations.
✔ Performed Follow-ups to CAPAs.
✔ Supported Root Cause Investigations.
✔ Executed Customer Complaints Investigations as required.
✔ Performed Trends Analysis of Customer Complaints (PIRs) for presentation in
Management Forums.

▪ Bbraun Medical Inc. Quality Engineer Intern (2018) – 6 months

✔ Supported in the Survey of Data and Execution of Improvement Projects.
✔ Supported in ETRs (Engineer Test Reports) Execution.
✔ Supported in Process Nonconformances Investigations.
✔ Provided Technical Support for Product Rework Processes (Leak tester setting).

LANGUAGES

Spanish – Native Speaker

English – Spoken and Written (Professional Competence)

COMPUTING

● Office Package
● Minitab
● SolidWorks
● AutoCAD
● MS Project

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 ● SAP
● TrackWise

COURSES

● Train the Trainer – INFOTEP

● Study of the Standard ISO 13485:2016 – Suprema Qualitas
● Internal Auditor ISO 13845:2016 – Suprema Qualitas
● ASQ Certified Medical Device Auditor (credential ID 63425704)

LABOR AND PERSONAL REFERENCES

● Eng. Nikauris Moscoso

Phone: 829-892-9446

● Miguelina Cornielle
Phone: 809-767-7976

● Eng. Rafael Sánchez

Phone: 849-750-0941

● Eng. Annivel Guzmán

Phone: 829-818-2310