Quality Engineer
Resume:
Pedro J. Colón Rivera
Urb. Monte Mayor calle Gacela #523
Dorado, PR, 00646
email: acergz@r.postjobfree.com
Qualifications
• Proven experience in technical and supervisory roles in the manufacturing areas of Medical Devices industries. Extensive exposure to production areas, compliance requirements, standard operational procedures, validation protocol execution and CAPA investigations.
• Broad knowledge of GMP, ISO 9002, ISO 13485, and Quality Standard regulations.
• Bilingual (Spanish/English) and computer literate in the use of PC - spreadsheets, word processors, and graphics software (Minitab, Word, Excel, PowerPoint, and Lotus Notes).
Experience
Jabil Circuit, Cayey PR January 2010 to present
Quality Engineer and Validation Engineer
•Managed and administered the control and compliance process of the quality systems or areas handled by quality inspectors.
•Maintained and controlled the manufacturing in-process and final packaging quality inspections, day to day operations quality issues, and assisted the execution of process and equipment validations.
•Analyzed quality control rejection trends for problems corrections; reported all non-conformances, investigation and verification of corrective actions in the manufacturing areas, and assured the completion of the Quality Goals.
•Developed and evaluated quality standards; performed and documented CAPAS investigations for all the customers and suppliers.
•Revised and approved validations protocols, manufacturing sop’s change request, and managed the Internal Audits and development of SPC programs.
Medtech Plastic, Vega Baja, PRJune 2005 to January 2010
Quality Engineer & Supplier Quality Engineer
•Managed and administered the control and compliance process of the quality systems or areas handled by quality inspectors.
•Maintained and controlled the manufacturing in-process and final packaging quality inspections, day to day operations quality issues, and assisted the execution of process and equipment validations.
•Analyzed quality control rejection trends for problems corrections; reported all non-conformances, investigation and verification of corrective actions in the manufacturing areas, and assured the completion of the Quality Goals.
•Developed and evaluated quality standards; performed and documented CAPAS investigations for all the customers and suppliers.
•Revised and approved validations protocols, manufacturing sop’s change request, and managed the Internal Audits and development of SPC programs.
Warehouse Supervisor April 2003 to June2005
• Supervised all warehouse employees; review their performance, as well as handled all employee related areas (hiring/training).
• Planned and distributed the workload in the best/appropriate manner to prevent delays or overloading conditions, and to assure on-time shipping of our customers’ orders.
• Shipped products to customers and developed different systems of inventory assessment to improve efficiency.
QA Inspector May 2001 to April 2003
• Measured and inspected different plastic products to assure their compliance with the required specifications and quality standards.
Professional Accomplishments
o Selected as part of the team for molds transfers.
o Worked on the creation of SOPs, validation of equipment, processes and product.
o Trained manufacturing and quality personnel.
o I also was the person in charge of the quality indicators report and MRB meetings.
o Reports were completed as per plan.
o Developed the implementation system of the Statistical Process Control (SPC).
Education
Bachelor Degree in Industrial Engineering August 1998 to May 2003
Interamerican University Bayamón, P.R.
Pre-Engineering Courses August 1996 to May 1998
Frank Phillips College Amarillo, Texas
Training & Seminars
o ISO 9002-13485 internal auditor certification
o Lean Manufacturing Leader certification
o Green Belt certification
o Warehouse Training
o Good Manufacturing Practice (21 CFR/Sec. 211)
o Supervisor Work Shop
o Analytical thinking. Statistical and Engineering knowledge.
o GD&T Seminars
o Statistical Process Control Certification
o Knowledge in use of PC- Spreadsheets, Word Processors and Graphics software (Minitab, Word, Excel, Power Point and Lotus Notes)
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