Quality Assurance Medical Device

RESUME COVER LETTER

Jose L. Ayala

*** ******** ***** ****** *******, FL 32825

Home: 407-***-****

Cell: 407-***-****

Email: **********@*******.***

*/**/****

Dear HR Representative

I have a passion for creating solutions and driving results for my customers and my company. I would like the opportunity to bring my skills to your company in your quality department. I have quality and regulatory experience in addition to have passion for developing products that saves and or improves people lives. Some of the highlights of my background include the following:

Management Experience – As a Quality Assurance and Regulatory Affairs Manager with LaserSight Technologies Inc, I have developed a solid Background in planning and executing projects. Hands-on manager with highly developed negotiation skills and experience cultivating strategic plans. I developed the plan and scheduled for regulatory testing of our refractive surgery Excimer laser to comply with the electronic medical device regulations and CE mark. I am in charge for developing the strategies for the existing and new products introduction to South America Market and creating new markets and work with Ministries of Health to register our products in Middle East, Europe and South America in addition to perform a direct work with the US government for export permit authorization.

Team Building – As a QA/RA Manager I have being assigned as a team leader to recruit and hiring personnel for LaserSight Technologies and develop talents and creating effective training programs. I reorganized the training program in our company to be more in accordance to employee needs. I also have assembled a team to perform the changes to our product in order to bring them to regulatory compliance.

Communication – Effective communicator with well developed presentation and negotiation skills. Able to develop productive relationships with colleagues, customers and staff at all levels.

Project Management Experience - Decreased the number of returning parts to the vendor by working and meeting directly with them to achieve a better product quality and reduce re-works. Project leader for CE Mark product compliance regulation.

I would like the opportunity to meet you in person and talk about how I can help you and your company achieve your goals.

You can reach me at 407-***-****-Home, 407-***-****-Cell or by email at **********@*******.*** . I look forward to discuss how I can bring value to your company.

Sincerely,

Jose Ayala

RESUME

Jose L. Ayala

545 Valencia Place Circle Orlando, FL 32825

Home: 407-***-****

Cell: 407-***-****

Email: **********@*******.***

Summary of Qualifications

BS in Biology with 18 years of professional experience.

12 Years of Laboratory Documentation Creation and Implementation, including laboratory SOP’s, Specifications, Quality System, Forms, Test Procedures, Protocols, etc.

18 Years of Regulatory Experience working with FDA and ISO13485 Agencies, including in charged of regulatory agencies audit, responses to FDA 483’s and ISO non-conformance observations.

18 years of CAPA system implementation and execution.

15 Years of management experience. Oversee up to 16 professionals, including interview, hiring and training laboratory personnel.

12 Years of experience in executing reports to Executive Management, including cost base analysis, employee performance, management reviews, cost reduction analysis, etc.

18 Years of Regulatory experience working with FDA and ISO audits in the medical device and biopharma industry

10 Year of providing laboratory documentation and testing support for IND, NDA, PMA applications

10 Years of project management experience. Executed multiple validation projects from development, protocol creation, review, execution, summary final report, etc.

10 Years of hands-on equipment validation experience. Executed of IQ/OQ protocols, testing procedures, SOPs documented change control and generation of final reports.

In charged of new product development commercial manufacturing transfer, etc.

18 Years of experience in the Bio pharma/medical device (7 yrs with refractive eye surgery laser devices)

Experienced on regulatory regulations like QSR 21 CFR 820, ISO 13485, CFR, 210/211 etc.

Excellent team player. Worked well with management, R/D and production personnel.

Willing to relocate and travel as required.

Professional Experience

LaserSight Technologies, Inc. – Winter Park, FL

Manager - Quality Assurance - 2004 to Present

Head of six quality assurance personnel, quality control functions (receiving, in-process inspection and product final release of laser systems, metal parts etc.) responsible for quality inspections for all operations in a refractive laser medical device manufacturing facility.

Maintained full responsibility of quality system requirements within LaserSight Technologies assuring that is effectively established, maintained, and complies with federal, state, local, and other applicable regulations, standards and procedures, achieving good standing within regulatory agencies

Documented change control functions, calibration, process validation, compliance of internal auditing, external auditing, supplier management, CAPA, Material Review Board (MRB) and complaint evaluation.

In charged of perform internal, supplier and external audits (e.g. FDA, EU Notified Body, & ISO 13485-2003 inspections), MDR and MDV reports, PMA annual reports for appropriate regulatory agencies.

Evaluated and performed changes as needed to field evaluation protocols and final report for product performance evaluation, which had increase, the product safety within the market.

In charged of working with regulatory agencies like Office of Foreign Access Control, Department of State and Commerce and overseas countries regulatory agencies for product registration and export regulations to countries like China, Iran, Syria, Europe and South America. Export approval licenses has being issued to our company and we had increase our customers client base by 50%

Completed of engineering change request, software changes and procedure changes.

Completed engineering change request, software changes. Responsible for photocopy and distribute engineering drawings, procedures and software to manufacturing and quality areas. Custody of Medical Devices technical files.

Pulled together an engineer team, acted as a team leader to executed electromagnetic and electrostatic troubleshooting in our refractive surgery laser system, which includes testing coordination with the testing lab and meetings with our engineers for proper corrective action plan.

In charged for Product CE Mark certification team, which had maintained the CE mark certification for the last several years

Reduced amount of customer complaints by taking appropriate corrective and preventive actions. Reduce the amount of complaints by 85%.

Implemented ISO 13485-2003-compliance system with no major observations from ISO.

Implemented and maintained a QSR system in compliance with 21CFR 820 with no FDA major observations for a class III and class I medical device.

International Sterilization Laboratory – Groveland, FL

Quality Assurance Manager - 2002 / 2004

In charged of a total staff of eight, including sterilization operators and customer service person in all day-to-day in medical device sterilization facility.

Executed the day-to-day activities of the Quality Assurance department for an ethylene oxide sterilization contract facility to ensure FDA and ISO13485 compliance.

Developed, reviewed and analyzed data, records and products to determine if quality standards and specifications are achieved. Non-conformance activities were reduced by 90%.

Formulated and maintains quality assurance objectives with production procedures to maximize product reliability and minimize costs. Operational cost were reduced by 45%

Reviewed cycle data for compliance to customer’s specifications, complaints handling, investigation, corrective/preventive action and reporting.

In charge of implement supplier non-conformance and CAPA system, work directly with customer to take appropriate corrective and preventive actions and reduced occurrences by 62%

Executed customer’s sterilization validation of new medical device products including performing sterilization cycle development and validation.

Executed internal audits, supplier audits, CAPA, and quality management reviews.

Company head representative for ISO 13485 and FDA inspections.

Baxter Healthcare Corp. – Jayuya, PR.

Quality Assurance Manager – 2000 to 2002

In charged a total staff of six in all day-to-day operations for a pharmaceutical and medical device manufacturer to assure attainment of regulatory, financial and business objectives in the quality assurance department.

Coordinated and performed environmental test monitoring, equipment and instruments calibration, and Steam and EO vessel qualifications for daily operations. Implemented a 3rd rotating shift to reduce manufacturing downtime and reduce operational costs.

Executed internal quality audits to assure full compliance with GMP requirements and regulatory agencies, like FDA, ISO, OSHA and Corporate assessments.

Wrote and executed equipment validation protocols which include IQ, OQ, PQ

Executed steam sterilization vessels validation protocols.

Reviewed and approved documents for system release like water for injection (WFI), compress air and sterilization vessel for product release.

Baxter Healthcare Corp. – Jayuya, PR.

Quality Control Supervisor - 1992 to 2000

In charged of a staff of sixteen microbiologists and laboratory technicians in all day-to-day operations during 3 shifts to assure attainment of regulatory, financial and business objectives in the microbiology lab.

Coordinated the environmental test monitoring for daily operations.

Prepared annual budget for microbiology lab and evaluate personnel performance.

Wrote and run validation protocols for laboratory equipment validation, product microbiological tests like LAL, bioburden, particles matter, distilled water testing.

Audited and trained manufacturing drug mixing personnel in aseptic techniques, equipment cleaning, pipe assembly and process documentation. This helped to reduce microbiological test out of specifications by 60%

Performed distilled water system monitoring, LAL test, solution particle matter test according to USP and annual qualification for microbiological tests.

Wrote and executed disinfectant efficacy validation protocols for laboratory equipment cleaning. This resulted in the decrease of amount of disinfectant used and reduction on the equipment sterilization exposure time.

Wrote and execute software validation protocols for LIMS and POMS (Product operation management system) increasing laboratory personnel efficiency.

Worked with engineering validation department to execute and perform trouble shooting on process validation, filing machine, sealer machines validations.

Performed internal quality and supplier audits to assure full compliance with GMP requirements and regulatory agencies achieving good standing with FDA, ISO and corporate head quarter.

Coordinated and performed sterility test for steam, EO vessel qualifications and new product development.

Created a microbiologists and production personnel team to developed strategies to reduced the number of out of specifications in our intravenous drugs and class I medical devices. Out of specifications decreased to almost zero occurrences.

Created and trained a microbiologists team in air conditioner filtration systems, Distilled water for injection systems function, design and blue print reading to analyze performance trend that help to detect environmental issues before it happens and environmental non conformance decreased almost to zero occurrences.

Education

University of Puerto Rico, Mayaguez, PR

BS – Major in Biology, Minor in Chemistry – 1992

Cum Laude

Skills

Languages: English and Spanish

Sanitation Standard Operating Procedures (sSOP), Equipment Validation, Project Management,

Software: Microsoft Office Product (Excel, World, Power Point, Outlook Express).

Standards: ISO 13485:2003, FDA guidelines, CFR21 section 820, 802,801, 840

Product import / export Standards, 801 and 802, GMP Regulations, ANSI/AMMI/ISO 11135 – EO Validation, Electrical / Mechanical Workmanship, USP guidelines

Trainings: Internal Audit Training, ISO 13485-2003, Environmental Testing, and Sterilization Cycle Development, Hazardous Material Air Shipping Cargo Certification.

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