Quality/Process Engineer
Resume:
Resume
Orlando Vargas Rodríguez
HC 02 Box 20304
Mayagüez, PR 00680
Home Tel. 787-***-****
E-mail ***********@*****.***
Professional Objective
Senior QA /Process Engineering position or similar
Support/Design Engineering position or similar
QA or Manufacturing Supervisor
Education
Bachelor of Science Environmental Engineering
KWU/ Warren National University
20 West 17 Streets, Cheyenne, WY 82001-4412
Tel 307-***-****
Bachelor of Administration
Columbia Collage
Box 3062 Caguas, PR 00698
Associate Degree in Computer Programming and Engineering
University oí Puerto Rico Mayagüez, Puerto Rico
Certifications
ASQ, CQE (Certified Quality Engineer) #26400
ASQ, CQA (Certified Quality Auditor) #4824
ASQ Senior Member #170445
Experience
2004 - Present
Position QA Engineer
Integra LifeSciences Añasco, PR, Inc
(Medical Device Plant) Tel 787-***-****
Report to the Director of QA. Responsible for the plan, creation, implementation and completion of approved quality validations programs, and test reports Team member of R&D to support manufacturing. Use of Engineering Quality & Tools (EQT) Create completed quality reports for new and existing products, process and equipment. Product Transfer, Quality Plans, Risk Analyst, Decision Tree, Design of Products DOD, FMEA, SPC, Sampling Plans Design of Specifications, Process, Product, and Machine Validations IQ,OQ,PQ. Quality cost, and data analysis. Provide statistical analysis of data to support the reports and to provide solutions to problems. Develop statistical based sampling plans for incoming in-process final and post sterilization inspections. Perform Internal and Vendors Supplier Quality Audits. Assist to plan, develop, implement and monitor quality programs and policies in compliance with corporate policies, FDA ISO, MDD and other applicable agencies.
1995 - 2002
Position SR QA Engineer
Surgical Specialties PR Inc, Rincon, PR (Medical Device plant) Tel 787-***-**** Report to the VP of QA/RA. Responsible as a team member of product design and for the to review Incoming, Process and Final Inspections criteria, methods and procedures to assure acceptable quality Standards are used consistently and effectively to support manufacturing operations. Review documentation related to product for quality improvements, products design creates new specifications and procedures as require. Monitor the system to identified skills, training and capabilities needed. Lead and work directly with Installation, Operational and Performance validations activities for Injection Molding Machines (IQ, OQ, PQ). Provide completed quality reports for new and existing products, process and equipment. Product Transfer, Quality Plans, Risk Analyst, Decision Tree, Design of Products DOD, FMEA, SPC, Sampling Plans Design of Specifications, Process, Product, and Machine Validations.
Position Documentation Manager
Surgical Specialties PR Inc, Rincon, PR
Report to VP of QA/RA. Responsible to assure documentation is in compliance to ISO, FDA, MDD CE-mark, and Canadian regulations. Assure current and latest documentation are available in areas of manufacturing, quality and engineering as well in sterilization, incoming, maintenance, safety, shipping and environmental departments. Support engineering design and manufacturing operations.
1991 - 1994
Position QA Engineer
Proper International Inc. Mayagüez PR
(Product for military applications) Tel 787-***-****
Report to the VP of QA/RA. Responsible for The design, planning, development implementation, validation and maintenance of the quality system throughout documented procedures in compliance to ISO, CE-mark and the USA Department of Defense.
1988 – 1990
Consulting - Providing specialist engineering advice and services to customers who require work in the quality field
1977 - 1988
Position Manufacturing Supervisors
Baxter Edwards Laboratories Inc. Anasco PR
(Pharmaceutical) Tel (787) 826- 2200
Report to the Manufacturing Director Responsible for all planning and execution of the production Hire and train new employees for the operations needed to meet production schedules.
Position Associated Facility Engineer
Baxter Edwards Laboratories Inc. Anasco PR
Report to the Facility Engineer Responsible for water treatment plant operation and maintenance Responsible for the spare parts warehouse system Order parts based on a perpetual inventory and Machine preventive maintenance. Coordinate with vendor pant calibrations schedules.
Computer Proficiency
Microsoft Word
Microsoft Excel
Microsoft Power Point
Microsoft Projects
Microsoft Office
Adobe Acrobat
Microsoft Office Visio
Minitab
Languages Proficiency
Spanish, English
References Upon request
Likely Compensation Salary 50k/year
Contact this candidate