Quality Assurance

Urb. Los Caobos calle Albizia #****

Ponce PR ****6

Cel: 787-***-****

Wandalí Seguí Román Email: *******@*****.***

SUMMARY OF QUALIFICATIONS

QA Manager with over 10 years of experience in the manufacturing environment within the Medical industry.

Outstanding supervisory experience. Vast experience executing internal audits, assure Compliance with Laws and

Regulations FDA and ISO. Immensely alert of the Safety and Occupational Health Policy and procedures. Strongly

skilled on procedures revision. Commendable experience managing QF quality issues. Determined to create quality

awareness (GMP, Procedures). Attentive to service. Highly motivated, self starter promotes teamwork and adequate

communication within others. Greatly organized and reliable to promote and maintain a safe working environment.

Absolutely qualified to manage the Laboratory equipment and the Steam Sterilization Autoclave. Computer knowledge

(MS Office). Knowledge in Production Management Systems, QSI, GMP, OSHA and FDA. Bilingual in Spanish and

English. Strong knowledge on Ploblem Solving and Communication skills.

PROFESSIONAL EXPERIENCE

COOPER VISION, Juana Diaz, PR

Quality Assurance Supervisor (2004-2005/2006-present)

Supervise and plan work schedule to the Quality Assurers Inspectors.

Conduct the Kronos payroll for the team employees.

Assure that all Manufacture products meet the parameters of the sterilization process.

Guarantee that all employees use safety equipment on designated areas.

Evaluate, coordinate and confirm that the disposition of the Non-conformant product is complete to

release and marked per the established monthly goal.

Train Q.A. and Manufacturing personnel according to the Company’s Procedures and Regulations.

Certify for the equipment calibration and the Validation Process are approved and complete.

Execute Procedures Revision and create Procedures for new equipments.

Complete all documentation process to validate new laboratory equipment for QA final Test.

Assist International Customers about the test results of released products, prior to be shipped.

Execute internal audits to Manufacturing Department, QA Final and Sterilization Area.

Assist on the FDA and ISO audits.

Attest that QA Final and the Sterilization areas are organized conform to the regulations and 6S

program.

Apply Lean Six-Sigma Techniques.

Providing Capabilities to Work Unit

Assist International Customers about the test results of released products, prior to be shipped.

Assuring Compliance with Laws & Regulations

Assist in:

Sterilization Equipments Troubleshooting

Demounting Equipment Troubleshooting

Finished Goods Management

Managing QF Quality Issues

Reviewing/ Approving NCRs Disposition

Initiating Non-Conformance Resolution

Non-Conformance WIP Management

Initiating SU's Non-Conformance Resolution

Selected Accomplishments:

Achieve Corporate Goal. Implement pH test solution for criteria acceptance to lots Release. This

achievement included. Conduce and complete validation process for pH meter. Revised

procedure, create new procedure and train Quality Assurance Operators .

Rework and Release 3 millions of non-conformance product in one month. This include develop

reprocess protocols accordance with Quality standards and Regulation, organize a rework group

and train this employers on protocols development, analyst data and give product disposition.

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Senior Compliance Analyst (2005-2006)

Conduct Internal Audits of the Manufacturing Process.

Submit corrective action to maintain the Process Control per the ISO, FDA Quality Standards.

Assist International Customers about the test results of released products, prior to be shipped.

Establish preventive actions to the Manufacturing Process.

Execute Procedures Review.

Defining Tactics for Quality First Pass, DPM & CPM Metric (Once a Year)

Providing Quality Documentation Approval

Providing Quality Awareness

Ensuring Completeness of Quality Investigations

Evaluating Quality Issues Reports at Mfg. & QA Final

Investigation (Data gathering of Quality issue)

Identifying and Implementing Corrective/Preventive Actions

Preparing Rework Protocols or memos for NCRs

Reviewing/ Approving NCRs Investigation & Disposition

Investigating NCR

Monitoring & Measuring Quality KPI's

Keeping BU's aware of actual Quality KPI's

Developing Actions to improve Quality KPI's

Developing supporting Documentation for QI

Providing Training for QI

Providing Support for the QI Start-up

Evaluating NCR

Completion of NCR

Investigating Quality Feedback

Monitoring Incidents and First Acceptance data

Developing Procedures for QI

Performing quality compliance inspections as per applicable TP's

Dry process batch release

Quality Assurance Inspector (2000-2004)

Audit the finished goods according to the Company’s established procedures specification.

Review and approve the Sterilization Cycle.

Review and approve the final product for market.

Perform the equipment calibration.

Audit Product test in the Validation Process.

Verify the continuity of the preventive maintenance equipment.

Perform PH Test, PRASA Test, water content test as requested.

EDUCATION

Pontificial Catholic University, Ponce Puerto Rico

BS in Biology

With a Minor in Ambient Science

University of Puerto Rico, Utuado Puerto Rico

Associate Degree in General Sciences

TRAININGS, CERTIFICATION AND SEMINARS

Auditor ISO 13485 Certified

DDI Development Dimensions International Inc.

Lean Six-Sigma Certified –Yellow Belt

6S Program Certified

SPECIALIST/alist Logistics Coordinator

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