Engineer Manufacturing
Resume:
Kevin D Colon
San Juan, PR 0091
**********@*****.***
Summary of Qualifications
Dynamic and result-driven engineer with experience in the Electronic and
Medical Devices Industries. Hands on experience on diverse projects such as
manufacturing transfers, qualification of new suppliers and implementation
of new quality system. Quality and teamwork oriented with excellent
interpersonal and communication skills. Computer literature in Microsoft
Office. Strong exposure to software; Kronos, SAP, Minitab, Auto Cad,
Statgraphics, Pspice, AS/400 and Advance Design System (ADS). Bilingual in
Spanish and English.
Accomplishments
. Contributed on the completion of the transfer of the whole Maquet
Cardiovascular manufacturing operations from Dorado, PR to Wayne, NJ
within the planned schedule.
. Reduced 30% of the scrap rate of Heartstring and Ultima finished good
products by training Distribution Center personnel on new visual
inspection criteria of finished goods products.
. Reduced the release process and Non-conforming Material Reports of the
annealed suture subassembly by eliminating the double inspection
performed by the quality inspectors and the operators.
. Achieved the re-certification in ISO 9001:2000 of the Heraeus
Noblelight of PR manufacturing plant by developing and implementing a
new quality system in the plant.
Professional Experience
Bard, Humacao, Puerto Rico
August 2010 to present
Quality Engineer
. Reviewed and approved Installation Qualification protocols and reports
for manufacturing equipment.
. Created Change Requests in order to update Standard Operating
Procedures, Manufacturing and Inspection Procedures.
. Trained personnel in new procedures and/or revisions of existing
procedures.
. Created and reviewed Risk Assessment documents in order to document
the action plan and impact of changes proposed to existing equipment
and processes.
. Actively supported as quality engineer the continuous improvement
initiatives.
. Actively participated in Kaizen Events for different manufacturing
lines and processes.
. Actively supported manufacturing area re-layouts and equipment
relocations.
. Determined and calculated the actual benefits of the implementation of
the continuous improvement actions.
. Audited the manufacturing line/processes after the implementation of
the continuous improvement actions based on Standard Worksheets.
. Performed root cause analysis.
. Developed action plan in order to implement correction, corrective and
preventive actions based on the root cause analysis of non-
conformances.
. Documented the evaluation and disposition of non-conforming products.
. Performed and documented gap analysis between corporate quality
standards and site standard operating procedures, manufacturing and
inspection procedures.
. Reviewed and approved corrective action and modification of preventive
maintenance for equipment.
Maquet Cardiovascual, Dorado, Puerto Rico
2007 - 2009 Previously Boston Scientific
Quality Engineer II
. Performed and documented analysis and investigations in order to
determine the root cause of non-conformances and customer complaints.
. Documented and implemented corrective and preventive actions in order
to avoid the recurrence and/or occurrence of non conformances and
customer complaints..
. Evaluated and performed disposition of non-conforming products.
. Created, reviewed and approved Engineering Orders for Standard
Operating Procedures, manufacturing instructions, raw material and
product specification documents.
. Actively supported the manufacturing transfer project of the
Heartstring Shunts and Ultima lines from Santa Clara, CA to Dorado, PR
by reviewing and approving validation plans, protocols and reports and
performing line verifications.
. Actively supported the manufacturing activities of the Ablation
manufacturing line.
. Supported the decommissioning activities of the Ablation manufacturing
line.
. Supported and participated on the Distribution Center transfer project
by providing feedback on procedure changes and/or creation for the
release of finished goods products.
. Trained manufacturing and quality personnel in new procedures and new
revisions of existing procedures.
. Supervised and managed the schedule of four quality specialists and
one quality technician. Reviewed and approved their timecards and
overtime.
. Reviewed and maintained periodically the Heartstring and Shunts
Quality Specialist Certifications.
. Teamed with Marketing and Supply Chain departments in order to
implement mechanisms to avoid backorders.
. Evaluated and approved documents related to components, equipment and
tools such as component qualifications, equipment entries and
qualifications, first article inspection reports, lost equipment
notices and out of calibration notices.
. Managed and scheduled the release of finished good product, work in
process and sub-assemblies in order to avoid backorders and line
stoppers.
. Prepared metric results slides for management review meetings.
. Supported external and internal audits.
. Reviewed and approved bioburden recovery procedures for the
Heartstring and Shunts products.
. Reviewed and approved quarterly sterilization dose audit reports for
the Heartstring and Shunts manufacturing lines.
. Performed the investigation to determine the root cause of the
Heartstring 3 dose audit failure.
. Investigated and implemented corrective actions for out of control and
out of specification points
. Developed, reviewed and created Master Validation Protocols and
Reports for the Acrobat, Xpose, Ultima, Blades, Heartstring and Shunts
manufacturing lines during the Dorado to Wayne transfer.
. Developed, reviewed and created Process and Product Validation
protocols and reports for the Acrobat, Xpose, Ultima, Blades,
Heartstring and Shunts manufacturing lines during the Dorado to Wayne
transfer.
. Reviewed and approved Sterilization Validation protocols and reports
for the Shunts, Heartstring and Acrobat manufacturing lines for the
Dorado to Wayne manufacturing transfer project.
Heraeus Noblelight of PR, Cayey, PR
2006 - 2007 Quality Engineer
. Supervised the incoming inspection, document control, calibration
section and quality control activities.
. Reviewed and approved Engineering Change Orders.
. Evaluated suppliers' performance and delivery.
. Performed evaluation of new suppliers for their approval.
. Coordinated the implementation of new product testing.
. Evaluated and performed disposition of non-conforming products.
. Modernized the document control system by implementing and uploading
electronically the specification documents of the finished goods and
subassemblies to SAP.
. Tracked the implementation of corrective and preventive actions
assigned to other departments.
. Developed and reviewed standard operating procedures.
. Developed and implemented a quality system that met the standards of
ISO 9001:2000.
. Developed and kept on track the internal audit schedule of the Quality
System. Performed audits and documented results of the audits.
. Reviewed, analyzed and document scrap reports.
. Teamed with sales organization in order to implement a new process to
reduce customer complaints.
. Trained employees on new procedures and revisions of existing
procedures.
. Trained employees on ISO 9000 standards.
. Scheduled and leaded the management review meeting.
Medisearch Puerto Rico, Guayama, PR 2005 -
2006 Value Engineer
. Established the metrics to measure the line performances by production
output, quality and safety.
. Implemented kan ban systems in production lines.
. Performed daily cycle count of raw materials.
. Evaluated and controlled the finished product inventory levels.
. Planned and scheduled the production operations (Master Scheduler).
. Determined labor loading in order to fulfilled the production schedule
requirements.
. Maintained the manufacturing instructions up to date.
. Determined time standards for the manufacturing processes of the
thermacare and fluid warmer product lines.
. Re-designed layout of the manufacturing lines.
. Performed and documented the results of internal quality audits.
Raytheon, St. Petersburg, FL 2002 -
2004 Electrical Engineer
. Involved in processes related to software licenses and their financial
justification.
. Developed specifications for the Space Transport Segment of the Mobile
User Objective System (MUOS) project.
. Modeled the parasitic effects of lumped components in order to develop
a component library for the Advance Design System (ADS) software.
. Performed characterization testing on components and circuits to
verify associated performance. Assisted with modeling efforts.
Documented all test and modeling results.
. Performed failure analysis to RF Switches, Oscillators, Quick
Disconnects, RF Cables, resistors and capacitors.
Education
Polytechnic University of Puerto Rico, Hato Rey, PR
Masters Degree in Manufacturing Engineering - 30 credits completed
University of Puerto Rico, Mayaguez, PR
B.S. Electrical Engineering (Magna Cum Laude)
Training
EtO and Radiation Sterilization
Raytheon Six Sigma
AQS Medical Device Certification Training
ISO 9001:2000 Lead Auditor Training
Health and Occupational Safety (OSHA)
cGMPs
Electrical safety
Electrostatic Discharge
Chemical Hazard
Ethics Training
Investigation and CAPA for Human Errors
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