Jaime Restrepo

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Quality Engineer

Jaime has diverse quality engineering as well as supervisory experience in the medical device and diagnostic industries. He has hands-on experience with product transfers, incoming inspection, manufacturing operations, and quality control. He is extremely familiar with manufacturing production equipment, cGMP documentation,and quality systems.

 

EXPERIENCE…
  • Coordinated hematology pilot builds for clinical release. Developed process methods for more than 40 assemblies, qualified requirements, evaluated performance and mitigated quality concerns.
  • Transferred project criteria for a modular catheter device from US to Mexico. Released more than 400 engineering specifications and integrated more than 90 suppliers into system within a 6 month period.
  • Enhanced manufacturing processes and re-engineered 100 production specifications to reduce rejections and performance failures.
  • Designed solutions to resolve out-of-box failures for electromechanical devices used to correct vision impairments.
  • Supervised Quality Inspectors in Receiving Inspection. Leveraged team abilities in closing non-conformance events, expediting batch releases and revising documents to capture process accuracy.
  • Performed documentation gap analysis on inspection procedures, investigated and resolved GDP issues and cycle counted OEM lots.
  • Key liaison with suppliers of machine tooling and industry machinery in Southeast Asia. Evaluated new products, addressed field complaints and introduced new means of documenting corrective actions. Reported on suppliers R&D activities, quality systems and manufacturing methods.
  • Oversaw CNC equipment qualifications verified set-up requirements, ran dry cycles and adjusted parameters to
    compensate for variance. Instructed customers with interface, features and maintenance. Created service schedules and updated quality documents.
  • Managed project teams to integrate hematology pilots into existing legacy lines. Teams developed manufacturing methods for more than 40 assemblies, qualified build requirements, charted project status and integrated lean principles to work stations. Streamlined process routers, introduced interchangeable parts, standardized assembly techniques and designed hands-free fixtures.
  • Maintained manufacturing stability for mechanical, electrical and pneumatic assemblies. Resolved end-of-life components, corrected design incompatibilities and monitored processes equipment. Revised techniques to eliminate work redundancy and robust testing procedures.
  • Justified supplier changes and non-conformance materials. Initiated protocol, designed acceptance criteria, setup and ran experiments. Conducted gap analysis, performed cycle testing and presented recommendation to quality assurance. Coordinated and managed floor changes, purged quarantined inventories and documented information into quality and material planning systems.
  • Communicated with diverse teams to resolve reoccurring consumer failures. Opened CAPAs to initiate root cause investigations. Started top-down analysis of system, modular and feeder-lines performance requirements. Outlined cause and effect results, traced process changes and researched component materials. Set-up dedicated stations to duplicate field issues and introduced worst case scenarios to parallel testing efforts. Oversaw performance results, gathered supporting evidence and presented finds and recommendations during peer reviews.
  • Coordinated outside manufacturing of catheter balloons, sheathing and stents determined significance of project transfer drawings and created overall inspection requirements for single level components.
  • Evaluated alternative design solutions to resolve out of box failures and gearbox seizing induced by design incompatibilities and corrosion caused by saline solutions.
  • Supervised machining operations for CNC production lines. Calibrated cycle times, structured process cells, organized tooling cribs and purchased pneumatic fixtures to reduce set-up times. Re-engineered 100 production specifications to decrease rework rates and rejections.
  • Managed production quality programs and conducted First Article Inspection Report to approve engineering changes, batch acceptance and outside processes. Lead in-house seminars in meteorology methods, Statistical Process Control, and Geometric Dimensioning and Tolerance. Evaluated inspection techniques via R&R gauge studies. Quantified SPC trends, justified process deviations and managed non-conformance materials. Created procedure for administration, receiving inspection, service and packaging areas.

 

POSITIONS HELD…
  • Quality Engineer – BioTeknica, Inc.
  • Production and Quality Supervisor – Boston Scientific
  • Manufacturer Engineer – Boston Scientific
  • Operations Engineer – Beckman Coulter
  • Mechanical Drafter – Cordis J&J
  • Mechanical Engineer – Bausch & Lomb
EDUCATION…
  • B.S., Mechanical Engineering – University of Miami