- More than 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 the Manufacturing - Operations organization.
Senior Quality Systems Supervisor
- Supervised leaders, technicians, inspectors and contractors (14 people) in the 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 the development and implementation of goals, objectives, policies, procedures and systems pertaining to the QA/QC Organization.
- Ensure compliance to all customers, QSR, cGMP, ISO 13485 and Medical Device Directive requirements.
- Manage and maintain the 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 the implementation of the “Camstar” Manufacturing Execution System (MES) in the Production environment.
- Successful coordination of Non-conformance System while maintaining less than 40% of NC reports over 60 days of aging by actively participating as an MRB member.
- Leading the 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 the Sterility Assurance Coordinator and Facilities Manager in the environmental monitoring program to insure natural bioburden of the device is not adversely impacted by the 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.
Quality Assurance Engineer Failure Analyst
- Performed detailed analysis of returned products in order to determine failure mechanisms.
- Recommended and participated in the implementation of the applicable corrective actions to determined failure mechanisms.
- Completed database and administrative activities into the Customer Complaints System in order to generate on time Failure Analysis Reports.
- Documented all information according to the Cordis Policies, procedures of the health, safety and environmental areas of Confidential and Confidential Corporation and Quality System Regulation Standards.
- Opportune communication of observed situations during complaints analysis that might require attention of the 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.
- 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 the Staff Members in the 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