CAREER SUMMARY

• More TEMPthan 10 years as an strong and enthusiastic QC Supervisor and QA Engineer solving problems and leading Quality Technicians and Inspectors by promoting quality achievement and improving performance throughout teh Manufacturing - Operations organization.

WORK EXPERIENCE

Confidential

Senior Quality Systems Supervisor

Responsibilities:

• Supervised leaders, technicians, inspectors and contractors (14 people) in teh Quality Assurance Organization in accordance with company policies in order to provide production support. Responsibilities include interviewing, training, coaching, assigning and directing work, appraising employee performance.
• Formulate and manage teh development and implementation of goals, objectives, policies, procedures and systems pertaining to teh QA/QC Organization.
• Ensure compliance to all customers, QSR, cGMP, ISO 13485 and Medical Device Directive requirements.
• Manage and maintain teh Company’s quality inspection and product release programs for in-process materials and components, assemblies and sterile finished goods by updating ERP System (QAD) to release and transferring product to its applicable stock/floor/FG locations.
• Cross functional team member for teh implementation of teh “Camstar” Manufacturing Execution System (MES) in teh Production environment.
• Successful coordination of Non-conformance System while maintaining less TEMPthan 40% of NC reports over 60 days of aging by actively participating as an MRB member.
• Leading teh group in performing risk analysis, root cause analysis of non-conforming product, in concert with other departments.
• Identification and recommendation of corrective and preventive actions resulting from product evaluation activities.
• Publishing QA reports and metrics of Quality/Manufacturing activities per required frequency.
• Conducting quality system audits as required per schedule as well as actively supporting Internal and External audits (BSI, FDA, Anvisa, etc).
• Generating, reviewing and approving updates or first releases needed to documentation in Agile.
• Working in conjunction with teh Sterility Assurance Coordinator and Facilities Manager in teh environmental monitoring program to insure natural bioburden of teh device is not adversely impacted by teh manufacturing environment.
• Supporting sterilization validations, reviewing product qualifications, component verification activities and implementation of inspection tools and methods.
• Supporting activities related to product field complaints and returned goods (Used, Unused, Complaint and Field action related) thru RGA Department, Pathology & Decontamination Sites, NPD & OPS departments up to their final destination or destruction as required.

Confidential

Quality Assurance Engineer Failure Analyst

Responsibilities:

• Performed detailed analysis of returned products in order to determine failure mechanisms.
• Recommended and participated in teh implementation of teh applicable corrective actions to determined failure mechanisms.
• Completed database and administrative activities into teh Customer Complaints System in order to generate on time Failure Analysis Reports.
• Documented all information according to teh Cordis Policies, procedures of teh health, safety and environmental areas of Johnson and Johnson Corporation and Quality System Regulation Standards.
• Opportune communication of observed situations during complaints analysis that might require attention of teh management or other areas involved.
• Coordination & conduction of new hire orientation.
• Responsible for Wage/Direct Personnel Certification Program.
• Supervised 6 skills trainers.
• Led implementation of company training activities.
• Administrated scholarship (Languages, Professional & Masters) and high school programs.
• Participated in QSR and FDA regulations audits.
• Fully accountable for training legal aspects.
• Responsible for Training Curricula, Training Needs Detection and Training Calendar/Metrics System.
• Coordinated mandatory companywide annual training (QSR & QUEST).
• Administrated of training rooms & audiovisual equipment.
• Updated “PRISMA” Training Records data base.
• Facilitated external and J&J trainings.

Confidential

Training Supervisor

Responsibilities:

• Coordinated Training System of two sites simultaneously.
• Supervised 8 skills trainers in charged of Control Certifications in Specific Operations (Direct & Indirect Level of production floor).
• Responsible for training legal aspects, QS 9000 audits and implementation of ISO 14001 System.
• Led selection, training and following up of direct & indirect hired personnel.
• Performed Training Needs Detection and Master Annual Training Plan.
• Worked in design training manuals and tests.
• Facilitated KAIZEN Teams Program. Leadership, Human Relations and Teamwork skilled.
• Coordination of SEE (Governmental Employment Agency) and Scholarship Programs.
• Worked with teh Staff Members in teh Annual Improvement Plan (Quality, Productivity, Costs, etc.) and involved in all Plant Campaigns ("Shiny Clean", "Security and Environmental", "Health Race", "ISO 14001 Follow Up", etc.).
• Administrated training rooms & audiovisual equipment.

Confidential

Administrative Assistant

Responsibilities:

• Coordinated training legal aspects, detection of training needs and ISO 9000 audits.
• Facilitated new hire orientation. Human relations and teamwork skilled.
• Updated FPY, Process & Quality Audits Reports (Control Graphs, Summaries, Charts, Presentations, etc.).
• Worked with Document Control Department in deviations control, documentation translation & revision of procedures, work instructions and visual aids, etc.