Ariel Mercado

**** ****** ***** *** **** Richey FL. 34655

ad4ap3@r.postjobfree.com

Tel. 727-***-****

EDUCATION

Computer Science, Associate Degree – Huertas Collage – Caguas, PR

Industrial Mechanic, Technical Degree – Mech-Tech College – Caguas, PR

CERTIFICATIONS

Refrigeration and AC, Certificate – Huertas Collage – Caguas, PR

OSHA 24 CFR 1910.120 STANDARD – Medtronic - Juncos PR.

White Belt Lean Six Sigma Certification – Oscor - Palm Harbor FL.

IPC-A-610-Solder Training Course – Invivo – Gainesville FL.

PROFESSIONAL EXPERIENCE

Mettler Toledo Lutz FL. 09/2021 – 06/2023

Quality Engineer

Performs root cause analysis, and implement change to continuously improve the quality of products and processes. Using SAP program process ZI, ZV and ZX QN’s.

• Take ownership of tracking, documenting and driving improvements to reduce overall costs while improving quality – oversee and spot check all documentation to ensure compliance to safety and corporate guidelines.

• Create, implement and enforce SOPs for Quality on the Production Floor and in FAT Workspaces.

• Participate in technical specification reviews by providing quality-related specialized knowledge and guidance.

• Provide Metal Detection Product Build and Inspection Training to lower-level quality professionals, as well as, to cross-departmental employees.

• Develop in-process inspection process for inspecting units at each station of build process for Metal Detection.

• Conduct product assembly set up and system de-bug of more complex systems.

• Manage and participate in customer driven Metal Detection systems Factory Acceptance Test (FAT) protocols along with internal FATs (as needed) ensuring machines are built and function to customer and Mettler-Toledo specifications.

• Notify and explain machine deficiencies discovered in Final Inspection and Factory Systems Test (FST) process to Test Engineer, Design Engineer, and production management.

• Drive lead time improvement by monitoring, reporting, and shortening rework times.

• Maintain professional and technical knowledge by attending educational workshops; sustaining job related certifications, reviewing professional publications and establishing business networks.

Oscor inc. Palm Harbor FL.

Quality Supervisor 12/2018 – 09/2021

Serve as Quality Supervisor in plant supporting manufacturing.

Collaborate cross-functionally to determine resolution for manufacturing issues.

Review manufacturing investigations, CAPAs, Change Controls and Revisions

Review/approve manufacturing batch records.

Real time review of all documentation supporting operations and release activities.

Reduce non-conformances to drive compliance.

Perform FDA audits for a RECALL and internal audits.

Support Quality, Person in Plant team development, participate in the MRB meetings.

Review all RGA’s and clarify any questions regarding reason for return.

Ensure RGA’s are logged and forwarded to the appropriate department for processing.

Ensure disposition of the RGA is completed.

Monitor Product Hold locations of RGA’s pending investigation and disposition.

Develop RGA Metrics, monitor and report to Management.

Conduct periodic RGA meetings to discuss metrics and to determine appropriate dispositions as required.

Assist with Quality Operations Special Projects Other duties as improvements using 5S Lean six sigma.

Baxter Largo FL. 07/16 – 12/17

Quality Assurance

Responsible for endorsing process and product quality, efficacy, and safety through the routine assessment of plant operations and finished products. Responsible for ensuring adherence to the regulatory and procedural requirements that govern those operations and products. Monitor product quality through the performance of required reviews to visual and functional testing documentations.

Adheres to all environmental, health and safety SOP’s, equipment, policies and procedures, including any department specific requirements.

Inspection data into failure tracking in GSP, TDM and AS400 programs.

Performs audits of work areas for compliance with appropriate procedures.

Responsible for data entry/management of nonconformance activities. Responsible for releasing product per standard operating procedure.

Monitor product quality through the performance of required Visual and Functional Testing. Maintain a working knowledge of statistically based Sampling Plans and their applications.

Responsible for gathering, analyzing, summarizing and distributing process-relevant DHR data.

Philips Gainesville FL. 08/15 - 06/16 (Temp.)

Quality Incoming Inspector II

Use SAP program for all inspection drawings.

Working knowledge of IPC-A-610, digital caliper, electrical meters.

Reads and interprets materials, such as work orders, inspection manuals, and blueprints to

Determine inspection and test procedures.

Inspects materials, products and work in progress for conformance to defined requirements

(Engineering drawings and specifications) using caliper, micrometer and electronic miter.

Marks items for acceptance or rejection, records test results and inspection data,

In addition, compares findings with specifications to ensure conformance to standards.

Test and measures finished products, components or assemblies for functioning, operation,

Accuracy, and to verify adherence to functional specifications.

Geometric Dimensioning and Tolerance (GD&T) metal and plastic molding parts.

Read dials and meters to ensure that equipment is operating according to specifications.

Mc Neil J&J, Las Piedras, PR

Reviewer and Data Collector Leader for a Counsel Decree. 10/12 – 12/13 (Temp)

Leader of the work plan gathering utilities and equipment and instruments data required for the SAP system.

Conduct equipment and system assessment to update data and reflect the as built condition using share point

system. Verified, SOP, GMP and GDP, technical data from equipment or instrument.

Organized all manual and impressed documentation to founders and binders.

Ethicon LLC. San Lorenzo, PR 12/2010 - 03/2012(Temp)

Quality Technician

Reviewed and approved product MPs. Approved process validation protocols and reports for manufacturing

Processes. Served on incident triage team. Approved Environmental Characterization reports. Performed

Release of sanitary utility systems. Represented QA on NPI team, and performed lead investigations.

Reviewed risk assessments; supported automation activities, facilities, and environmental programs; reviewed and approved work orders, EMS/BMS alarms, and approved NC investigations. Approved change controls, provided lot disposition, and authorized lots for shipment.

Medtronic PR, Juncos, PR

Manufacturing Technician 11/2004 to 05/2008

Worked with engineering to implement new PM’s and trained others as appropriate, using Indy Soft program.

Transferred production line from Medtronic Mini Med California to Medtronic Puerto Rico. Supported

manufacturing regarding quality control issues and to reduce daily downtime rejects rate. Supported

equipment processes and product validation activities, IQ, PQ, and OQ Ismeca Costume Machine. Solved

advanced problems in the production line. Developed mastery on the equipment and production processes,

including System Maintenance, HVAC Operation, SOPs, cGMPs, and OSHA. Executed work orders for the

preventive maintenance of manufacturing equipment. Worked with 6S Clean Room.

St. Jude Medical P.R. B.V., Caguas, PR 2000 to 2004

Manufacturing Technician

Support and Troubleshoot problems with equipment, devices, or products in the manufacturing area.

Daily set-up to manufacturing equipment. Multivac and Branson washer machines.

Responsible for the start-up of the manufacturing machine and Quality inspection.

Provided preventive maintenance (PM) to manufacturing equipment.

INTEL PUERTO RICO LTD., Las Piedras, PR 1993 to 2000

SMT -Operator and Technical Support

Responsible for operating SMT machine and Quality inspection.

Provided preventive maintenance (PM) For the SMT Machine, Reuter, and ATMOS Oven.

Repaired feeders Back-up For SMT machine.

Manufacturing and inspection of electronic and mechanical components or assemblies

Welding, Machining and associated inspections

APQP/AS9145/ AS9102 (First Article Inspections)

Strong understanding in AS9100 and ISO 9001 Quality Management Systems.

SKILLS AND TRAINING

IBM PC and compatible systems, Micro Soft Office, Outlook, Internet.

Bilingual (Spanish and English).

8D.

EDMS, ESD.

SAP, GSP, QCBD, Share Point, Teams Center programs.

Lean manufacturing, 6S, Kaizen event and FTQ .

Solving problems skills.

Work in a strong diversity culture.

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