Eder Alor

Quality and Engineering Technician with 8+ years of experience in NPI, process development, administration, validation, and continuous improvement within medical and electronic device manufacturing. Certified in Lean Six Sigma (Black, Green, and Yellow Belts) and skilled in FDA, ISO, and IATF standards, as well as Core Tools. Experienced in process optimization, validation protocols, and leading cross-functional teams to ensure high-quality, compliant, and efficient production. with 8+ years of experience in NPI, process development, administration, validation, and continuous improvement within medical and electronic device manufacturing. Certified in Lean Six Sigma (Black, Green, and Yellow Belts) and skilled in FDA, ISO, and IATF standards, as well as Core Tools. Experienced in process optimization, validation protocols, and leading cross-functional teams to ensure high-quality, compliant, and efficient production.

3.1- JOHNSON & JOHNSON (Cordis) | 2023-2025
Quality Technician
As a Quality Technician, I played a key role in several projects, focusing on adapting and transferring Cordis’ quality processes to our manufacturer’s facilities (Foxconn) to produce 22 catheter models for brain or heart surgeries in compliance with the following standards: FDA 21 CFR 820, ISO 13485, ISO 9001, and IATF 16949.
Some of the key activities to achieve these objectives were:
•Designed and executed quality studies using tools such as CPK, PPK, and R&R to improve the process and ensure it is capable of producing high-quality products.
•Monitored and analyzed quality KPIs including PPM, rework, FTQ and SPC control charts, to support decision-making and achievement of operational objectives.
•Investigated and resolved product and process non-conformances using tools such as 8D, Ishikawa, and root cause analysis, implementing CAPA and rapid response actions to ensure process control and continuous improvement.
•Administered changes to technical and quality documentation in EDMS and ERP systems such as Master Control, Agile, Windchill, and SAP, ensuring proper implementation, traceability, and compliance with standards.
•Reviewed and approved critical documentation including FMEA, PC, DRR, MTR, MSA, MVP, IQ/OQ/PQ, TMV, SFV, drawings, and process/equipment documentation, and collaborated in internal, external, and regulatory audits including FDA, ISO 13485, ISO 9001, IATF 16949, and customer audits to ensure compliance and audit readiness.
•Planned and supervised quality personnel activities to ensure efficient execution of in-process inspections, first article release, and finished process validation.
•Provided training and technical support to inspector and production personnel on quality procedures, acceptance criteria, use of measurement equipment and deviation to ensure proper process execution and adherence to quality standard.

3.2- JOHNSON & JOHNSON (Cordis) | 2020-2022
Engineering Technician
As an Engineering Technician, I collaborated in the development of two new processes to manufacture three new catheter models for heart and brain surgeries, in compliance with FDA 21 CFR 820, ISO 13485, ISO 9001, and IATF 16949.
Some of the key activities to achieve these objectives were:
•Identified root causes of process issues using LSS tools such as DMAIC, A3, hypothesis testing, DOE, and Poka-Yoke to propose solutions and implement continuous improvement initiatives.
•Created and updated technical and process documentation, including SOPs, WIs, DHRs, and created and modified drawings, layouts, diagrams, and 2D/3D models using AutoCAD and SolidWorks and managed approvals in EDMS/ERP systems.
•Created and updated technical and process documentation including SOPs, WIs, DHRs and drawings, layouts, diagrams, and 2D/3D models using AutoCAD and SolidWorks to ensure accurate, compliant, and auditable process documentation.
•Managed ECO activities and implemented changes in EDMS/ERP systems and acting as a liaison between engineering and production to ensure proper implementation of changes.
•Developed and executed validation protocols including IQ, OQ, PQ, CSV, and TMV, executed tests, analyzed results, generated reports, and secured approvals in EDMS to enable product manufacturing in the developed processes.
•Supported process development and APQP validation phases, coordinating and executing activities for the PPAP package preparation, including reviewing/modifying drawings, developing FMEA and Control Plans, validating FAIs, performing dimensional analyses, capacity studies (Cp, Cpk), and generating supporting documentation to ensure compliance and readiness for production,
•Installed, configured, and maintained production machinery such as custom PLC equipment, thermoforming, robotics, and testing systems, by resolving automation, mechanical, electrical, and pneumatic issues to minimize downtime.
•Supervised and coordinated work teams, providing training on equipment usage and technical procedures to ensure continuous operations and enhance process robustness.

FLEXTRONICS INTERNATIONAL | 2014 -2020
NPI and validation technician
As an NPI Technician, I participated in the development of three new processes outsourced to suppliers (aluminum and steel part coating via anodizing and passivation, nylon coating, and logo/indicator application via screen printing) for the production of kits used in critical bone fracture internal fixation surgeries.
Some of the key activities to achieve these objectives were:
•Participated in the design of manufacturing processes, documenting each step, and developing standardized work instructions, flow diagrams, and control plans to ensure efficient transition from prototypes to mass production.
•Organized and supervised the construction of pilot units and conducted quality audits on prototypes to verify compliance with assembly drawings, BOMs, and work instructions.
•Collaborated with engineering, quality, and production teams in product design evaluations to identify potential manufacturing and assembly issues, analyzing results to recommend improvements and mitigate risks during early development phases.
•Supported the selection and validation of production tools and equipment, designing and fabricating new fixtures, templates, and jigs as needed.
•Specialized in detailed analysis of equipment, processes, to establish precise validation paths. Identified equipment requiring IQ, OQ, PQ, CSV, or TMV protocols, and collaborated in protocol development, test execution, and report preparation to ensure proper validation of equipment, processes, and installations.
•Analyzed key activities to achieve project objectives, strategically defining and coordinating tasks with technicians, while providing training and supervision to ensure successful objective completion.
•Proposed functional and statistical test designs for validations, considering sample sizes, statistical methods, and functional testing. Designed samples addressing specific characteristics and potential failure modes to ensure complete validation with robust statistical support.

INSTITUTO TECNOLÓGICO DE CIUDAD JUÁREZ
Mechatronics engineering with specialization in embedded systems (degree in progress).

INTERNATIONAL LEAN SIX SIGMA
Certification in Lean Six Sigma Black belt, Green belt, and Yellow belt.