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Quality Engineer /Manager

Location:
North Haven, Connecticut, 06473, United States
Salary:
65,000
Posted:
November 17, 2010
Email:
cgefbz@r.postjobfree.com
Contact Info:
*************@*******.***


SUMARY OF QUALIFICATIONS
*+ YEARS OF INDUSTRIAL ENGINEER IN QUALITY SYSTEMS & CONTINUOUS IMPROVEMENT EXPERIENCE.
FAST LEARNER AND HARD WORKER WITH TROUBLESHOOTING AND PROBLEM-SOLVING ABILITIES.
EXCELLENT INTERPERSONAL RELATIONS AND COMMUNICATION SKILLS.
RESULTS DRIVEN SELF STARTER AND TEAM WORKER COMMITTED TO QUALITY BILINGUAL SPANISH-ENGLISH.
CUSTOMER FOCUSED.

PROFESSIONAL EXPERIENCE
Acme Monaco Corporation Connecticut October 2009-March 2010
Manager of Device Compliance Medical Assemblies and Orthodontics
Maintenance of existing ISO accreditations (ISO 13485:2003 ISO 9001:2008 & TS-16949) and ensuring compliance with national and international standards and legislation.
Collaborates with Engineering on new product development and design review for quality/reliability issues.
Assure suppliers comply with Acme Monaco Corporation Quality Management System.
Develop and maintain the quality management system documentation including documents specific to regulatory and compliance processes and procedures such as the quality manual.
Perform audits of internal processes and procedures to ensure staff compliance.
Address process findings and non-compliance issues from both internal and customer audits.
Create and maintain process failure mode and effects analysis. (FMEA`s Control Plans etc)
Create and execute process validations and approve/verify protocols.
Manage CAPA system as well as develop and implement corrective actions. Analyze and review customer complaints.
B.Braun Dominican Republic Santo Domingo. February 2008 March 2009
BPS (B Braun Production System)/Lean Manufacturing Section Manager
Serve as change agent. Provide leadership coaching and training in lean thinking lean production variation reduction problem solving people strategies and the tools associated with the B.Braun Production System (value stream mapping spaghetti diagram six sigma 8 forms of waste takt time/cycle time muda walk etc).
Lead and deploy roll out of continuous improvement best practices throughout facility. Improve manufacturing process by understanding measuring charting and reducing variations in any negative impact on the process the product and costs.
Measure and analyze results of changes made with the objective of sustaining and continually building upon improvement. Assure predicted savings are tracked validated reported and applied.
Prepare and manage budget in support of capital project and manufacturing support activities.
Establish department goals in support of project and site wide priorities. Contribute to development of company priorities long-term strategies and goals.
Develop strategies for the implementation of Lean Manufacturing philosophy across organization. Train and mentor teams to drive improvement initiatives across organization.
Develop and coordinate trainings of Lean Manufacturing Tools and principles covering tools such as 5'S SMED one piece flow timing of production production management Kankan.
Create Value Stream Maps y Value Stream Design for process improvement.

B.Braun Dominican Republic Santo Domingo April 2007 February 2008
Senior Training Supervisor/Human Resources
Create training policy and procedures assuring compliance with personnel training needs and regulatory agencies requirements.
Supervise subordinate personnel including: hiring determining workload and delegating assignments training monitoring and evaluating performance and initiating corrective or disciplinary actions as applicable.
Manage the Job Descriptions System.
Manage the Training System ISOTrain. Creates training curriculums and training matrix modules training codes for employees and contractors upload training courses in the system among other activities.
Support the audit process.

EDE Este (Dominican Electricity Company) Santo Domingo. September 2005 April 2007
Process Improvement Engineer
Implement the Document Control System
Develop Standard Operations Procedures (SOP)
Create and Generate Reports
Develop Job Descriptions System and Organizational Charts
Supervise the employees of the Department
Developed and Implemented a Document Control System.
Standardized all process of the Commercials offices.

Davis & Geck Caribe Ltd Santo Domingo (Covidien) November 2004 September 2005
Document Control Coordinator
Responsible for Document Control Department (SOP updates change control process validation records)
Support internal and external audits processes. ISO certified Internal Auditor.
Project Management: Led continuous improvement projects of department such as lean validation Kaizen Events etc.
Ensure Good Manufacturing and Documentation Practices (GDP & GMP) experience with ISO 9000 13485 and FDA Regulations

Davis & Geck Caribe Ltd (Covidien) Santo Domingo June 2004 November 2004
CAPA/APQP Technician
Follow up with Corrective and Preventive actions and Customer Complaints of facility. Review analysis and perform effectiveness check
Support APQP program

EDUCATION
Operations Management Master Degree
Pontificia Universidad Católica Madre y Maestra Dominican Republic 2006
Industrial Engineering Bachelors Degree
Pontificia Universidad Católica Madre y Maestra Dominican Republic 2004

TRAININGS AND SKILLS
Feedback- Acme Monaco Corporation 2010
Lean Professional Certification - Lean Alliance 2007-2008
Problem Solving and Making Decisions - Kepner-Tregoe (KT) Company 2005
Supervision Management - Instituto Cultural Dominico Americano 2005
Lean Manufacturing Tyco Healthcare 2005
Internal Audit ISO 9000:2000 - Prisma Consulting 2004
Process Validation - Tyco Healthcare 2004
Software Validation and Industry Requirements - AMMI 2003
APQP (Advanced Product Quality Planning) Tyco Healthcare 2003
Process Validation - Stat a Matrix 2003

Software:
Office Package (Power Point Excel Word Project Visio)
ISOTrain (Training System)
Documentum (Document Control System)
SAP (MRP System)
EIKON (training System)