Responsible for the management of Supplier QA, Incoming QC, Calibration department and Failure Investigation / CAPA Management System related to these functions. Management of product Quality functions, Continuous Improvement initiatives, and development, implementation and effective verifications of investigations and corrective and preventive actions.Provide strategic direction for the QA/QC support of daily incoming inspection activities, including development of test and inspection methods, and completion of incoming inspection activities.Facilitate management and tracking of Management Review and Quality Performance metrics. Participate as a member of the FDA readiness team and provide technical support during FDA inspections and advise Body audits.• Developed manpower planning and utilization programs to satisfy actual and projected requirements, including the scheduling of overtime and the efficient use of temporary services to maintain department structure thus emphasizing daily priorities inspections.• Refined systems to provide a “look ahead” capability to streamline throughout and resolve chronic obstacles or delays. Implemented a Skip lot process to use the inspector time more effectively and moving inspection quicker. Over 25% inspection hours reduced thanks to this system.• Developed and maintained employee development and participation programs to increase the individual’s potential and added value to the organization. Extended the program to all levels from inspectors to supervisors.The incoming inspection department and supply engineers were encourage to submit Kaizen initiatives in order to enhance the process and areas, thus maintaining the department constant evolution. Some of these initiatives were used as pilots and then implemented in other areas.• Participated in budget preparation, controlled expenses within the approved plan and participated in Cost Reduction Programs.

Supervised the activities of the production personnel in the manufacturing / operations department. Planned, organized and monitored production workflow in manufacturing / operation. Performed monthly departmental Headcount and Machine capacity planning. Analyzed and adjusted department scrap, supply and miscellaneous budgets. Drove to meet departmental metrics (KPI’s), troubleshooted as required. Ensured compliance with company policies and procedures as well as safety programs and quality regulations. Responsible for interviewing, hiring and training team members as well as planning, assigning, and directing daily work. Worked cross functionally with Customer Service, Marketing, Engineering, Planning, Quality, R&D. Achievements:• Created and developed training plans for specific processes and team members. An enhanced training plan program was created with the purpose of developing resources to provide professional growth and maintain talent in house.Several resources were developed to the point where some were able to become leads, supervisors and engineering technicians.• Led and conducted Lean and Six Sigma projects.One of the projects resulted in the organization of the manufacturing processes by creating a linear process flow thus eliminating the non-value added steps.Production time was reduced by almost 50% and increased the On Time Delivery from 70% to over 98%. • Motivated and encouraged outstanding performance, team work, & morale. Working with multicultural operators, the language barrier was at times a road block. Contributed to the implementation of translator stations that helped the operators and supervisors understand each other more effectively.

Lead and maintain assigned quality systems and compliance functions. Sustain a state of compliance to applicable regulations and directives such as FDA, Quality Systems Regulations (QSRs), ISO 13485, Medical Devise Directive (MDD), Canadian Medical Device Regulation (CMDR), TGA and ANVISA requirements. Perform assigned internal audits to ensure compliance with all applicable quality system standards and directives in accordance with internal audit schedule. Coordinates preparations for and conducts quality system external audits and inspections. Achievements:• Developed training plans and roster for designated resources.Revised and updated new training plans as necessary. Depending on the task assigned additional responsibilities were provided and new products, new training plans and certification process had to be completed. In the time with the company I assisted in the creation of at least 50-75 new plans. • Perform training sessions for new process implementations.Created or assisted in the creation of at least 50-75 new plans for several new products introduced. Provided certification approval to each individual assigned to their specific plans.