Felix Le

Senior Quality Consultant

Felix has more than 20 years experience in quality systems, design assurance, manufacturing quality, supplier quality, and human resource management in the medical device and pharmaceutical industries with original equipment manufacturers, contract manufacturers, and consulting companies.  Felix has extensive knowledgeable of 21CFR and MHLW No. 169 regulations, ISO 13485 standards, and is familiar with other foreign medical device regulations.  Felix serves FDA regulated companies in various areas of quality system remediation and improvement with emphasis on resolution of regulatory non-conformance in response to FDA 483, warning letter and consent decrees.

 

EXPERIENCE…
  • Performed remediation of complaint files, updated corporate-wide management review process, CBT training, and related Excel tools, served as the supplier quality engineering SME, performed validation of non-product software and manufacturing software equipment, managed non-conformances and related CAPA activities.
  • Director of Quality for contract manufacturer  – Led and integrated global quality function including document control, calibration, microbiology, complaint handling, CAPA, design assurance, supplier/component quality, incoming inspection, manufacturing quality, training, customer/regulatory auditing for both domestic and international facilities, served as the Management Representative, and led organization through a Japanese PMDA audit that resulted in no observations.
  • Participated as a key member of the Medtronic corporate team in the development of the corporate guideline for process validation describing detailed requirements for inputs and outputs for IQ, OQ, PQ activities.
  • Managed the manufacturing quality function in the development of the Medtronic neurological implantable, programmable SynchroMed II drug pump that performed and tracked completion of all FMEA in support of process validation.
  • Led project to perform and track completion of manufacturing process assurance remediation efforts (IQ, OQ, PQ) including PPM, FMEA, equipment installation qualification, process characterization/ qualification/validation, and process monitoring.
  • Senior Quality Manager for OEM facility – Partnered with finished-good manufacturing facilities from Puerto Rico, Switzerland, Arizona, and The Netherland to ensure proper quality support for manufacturing process development, product transfer, and resolution of quality issues.
  • Led the supplier quality engineering department managing 125+ domestic and international key suppliers covering from raw materials to finished goods; established high-capability material inspection lab dedicating to inspection of prototype components in support of new product development projects.
  • Manufacturing Quality Manager – Implemented simplified Baldridge assessments (2) to identify, prioritize, and focus on top three improvement areas for quality/operational efficiency and effectiveness.
  • Led project to introduce the new V-wing anchor and the new introducer needle for the Medtronic Model 8703, 8709, and 8711 catheters – received Medtronic Star of Excellence Award for project management leadership.
  • Defined requirements and led IT project to convert paper-based Product Review Request system into a computerized web-based system improving operational efficiency and effectiveness; implemented system training and roll-out plan to 50+ engineering and production employees.
  • Led design assurance function for the development of the Champion cardiac pacing system for the start-up facility in Shanghai, China; performed system reliability prediction, design FMEA, technical assessment, system hazard analysis, and quality system audits, qualification plans / reports for EMC, mechanical, packaging, connector, and first article inspection.
POSITIONS HELD…
  • Senior Quality Consultant – BioTeknica, Inc.
  • Medical Device Quality Consultant – Felix Le Consulting, Inc.
  • Director of Quality/Regulatory – ATEL Medical
  • Senior Quality Engineer Manager – Medtronic, Inc.
  • Supplier Chain Quality Manager – Medtronic, Inc.
  • Manufacturing Quality Manager – Medtronic, Inc.
  • Design Assurance Engineer – Medtronic, Inc. 
EDUCATION…
  • M.B.A. – University of Minnesota
  • B.S., Electrical Engineering – University of Minnesota
CONTINUING EDUCATION…
  • ASQ Certifications – Medical Device Consulting
  • Lean Six Sigma Leadership – Pharmaceutical cGMP