Brendan Kelly

About Brendan Kelly

In 2022, I have delivered Action orientated activities based on data captured in the GEMBA to determine actions/owners & due dates to ensure accountability every-day. Delivered 60% increase in productivity after value stream mapping & 10 cycle analysis that identified constraint stations, which were immediately resolved and or removed. DEVELOPED ACTION LIST OF Short/Medium/Long term actions, critical to quality stations, that delivered attributes & station design refinements to be in specific sweet spots that reduced ergonomic injuries. I am accountable to deliver on commitments through smart goals with respect and humility. I am focused on Leading, developing, mentoring high performing teams. Focused weekly people coaching, reinforcement & coaching with no blame culture. This enables the building of world class teams that consistently deliver on or above commitments. Currently I am championing an operational excellence program to enhance performance that drive performance higher while reducing non-conforming product. Utilizing the Shingo principles, we are enabling best in class behaviors and team engagement. These culture changes led to further record-breaking results for AVCR Costa Rica.In 2017 AVCR exceeded expectations, through consistently delivering product in full on time and below standard costs. This achievement is even more significant as it was delivered with a record reduction in overtime which delivered $5MM+ Cost improvement. These improvements culminated in Zero audit findings during 4 regulatory visits during 2016 (FDA/BSI), record reduction in Non-Conforming product. I believe in creating win-win opportunities which drive a morale enhancing experience.Special assignment in 2017-19 at our Puerto Rico Guide Wire manufacturing site i formalized and executed on a 2-year Capacity ramp during transitional period. 14 Step & lean 6 sigma improvements and a product family transfer to the Island which delivered a 30% Capacity improvement, while reducing non-conforming product and improving online yields. Ramped & exceeded Volume commitment. Zero-defect initiative including identifying ‘critical to quality attributes ’to move detection capabilities and product containment to the left’. I am Experienced with CFR 820, ISO 13485/14971, EU MDR 2017/745 vs MDD registration renewal, remediation and site/process preparation. Familiar with CFR ICH medical devices GCP guide. Also completed latest Data Integrity & compliance training as it pertains to CGMP for the medical device industry.

Experience

1. Director Operations, Engineering, Maintenance and Calibration

   Abbott

   Sep 2014 — Present · CR

   Responsible for all Manufacturing Operations, at Abbotts Premier Medical Device Facility. Delivering High quality product while Ramping production at AVCR Costa Rica.in (3) Clean Rooms all Front line Engineering, Maintenance & Calibration departments, associated with High volume Manufacturing of 4MM BDC & SDS catheters at AVCR. Delivered record productivity (40% improvement in productivity and a 27% improvement in Yields resulting in $3MM+ Cost improvement). New Product Introduction. Record Savings, delivering product at below standard costs through a reduction in the variance of material usage, Engineering projects that delivered significant yield improvements and process simplification. Best in Class Overtime Reduction, Attrition reduction, Talent Development, Leadership and Strategic positioning.

Education

• North Wirral college of Technology

  Mechanical Engineering, Plant Design

Skills

• Fmea
• Quality Management
• Change Control
• Six Sigma
• Product Launch
• Quality Auditing
• Quality System
• V&V
• Process Simulation
• Minitab
• Design Control
• Spc
• Product Development
• Technology Transfer
• Iso
• Pharmaceutical Industry
• Sop
• Fda
• Tqm
• Manufacturing Operations
• 5s
• Tpm
• Team Leadership
• Continuous Improvement
• Validation
• Quality Assurance
• Design for Manufacturing
• R&D
• Quality Control
• Engineering
• Gmp
• Injection Molding
• Medical Devices
• Root Cause Analysis
• Capa
• Kaizen
• Value Stream Mapping
• Process Engineering
• Design of Experiments
• Manufacturing