Tai D Tran

1219 Gainsville Ave.

San Jose, CA 95122
TaiTran3535@gmail.com
408 569 6666

Manufacturing/Production Supervisor

Proven track record of performance with invaluable experiences

acquired within biotech, medical device and pharmaceutical
organizations. Skilled at all areas of Manufacturing Operations and
Management including cost containment and technology transfer.
Consistent leading Lean Manufacturing and High Performance Work
Teams and utilize strong leadership.

• GMP/cGMP and ISO compliance

• Lean Manufacturing
• Self Directed Work Teams
• Kaizen and 5S Programs
• Total Quality Management (TQM)
• Knowledge of Dr. Deming’s concepts

PROFESSIONAL EXPERIENCE

Interface Associates – Laguna Niguel, CA

9/1/08 – 11/21/08
Manufacturing Supervisor
Responsible for manufacture Balloon Catheter devices
 Ensure daily production schedules are met.
 Ensure proper employee training is completed to ensure safety and quality compliance.
 Assure that department/shift is properly staffed with capable people and that team
member skills are developed and improved.
 Develop and implement lean manufacturing processes within the balloon production
department.
 Work with planning to ensure the proper schedule is followed and we achieve on time
delivery.
 Work with balloon development and set-up operators to create a repeatable set-up process
and continuously reduce set-up and down time.
 Supervise and lead balloon production team members in meeting priorities. Handle all
supervisory responsibilities for personnel including training, work performance
evaluation, and disciplinary actions including termination of employment per company
policy.
 Create and maintain a work environment that fosters teamwork; provide coaching and
mentoring to all direct reports
 Track set-up and down time of each balloon forming machine.
 Track cycle time of all work orders.
 Track metrics by employee to determine performance.
 Track daily balloon production and daily yield information.
 Continuously work to improve yields in the balloons room, show improvement through
weekly tracking.
 Ensure consistent processes are followed by all in the balloon production department.
 Provide recommendations to build a department to support proper growth.
 Develop capacity models to support company growth and publish quarterly.
 Support the other product lines with good communication of issues that will affect their
schedules.
 Interface with other functional departments as necessary.
 Perform any other directly related appropriate duties as assigned.

Abbott Vascular- Temecula, CA

4/1/06 – 2/4/08
Manufacturing Supervisor
Responsible for manufacture of Drug Eluting Stent (DES) devices.
• Over 65,000 units produce yearly.
• Supervise 49 manufacturing operators before Lean Manufacturing was
implemented and 23 manufacturing operator after Lean Manufacturing but the
productivity equal or better before Lean Manufacturing.
• Leading the team to ensure timely production and delivery of finished good of
stents to inventory.
• Train personnel cGMP, operational tasks, Manufacturing Process Instructions
(MPI), Standard Operating Procedures and Safety policies.
• Maintain the production facilities, production processes, equipment and
documentation in accordance cGMP, quality system and ISO regulations.
• Play an active role in the development of employee’s careers.
• Revise Lot History Record (LHR) and eLHR, Manufacturing procedure
instructions and Safety Operating Standard.
• Perform annually performance reviews for employees . Set goals for employees
that tie with the department goal and company goal.

Hitachi Chemical Diagnostics, Inc. – Mountain View, CA

1/5/00 – 3/27/06
Manufacturing Supervisor
Responsible for manufacturing of In-Vitro Diagnostics devices.
• Over 700,000 units produce every year.
• Supervise 15 manufacturing associates in semi clean room environment.
• Ensure timely production and delivery of reagents and kits to inventory.
• Directed major initiative to establish High Performance Work Teams/Self
Directed Work Teams
• Create and guide Self Directed Work Teams that schedule themselves, equipment
and the production facilities to meet the production plan.
• Maintain the production facilities, production processes, equipment and
documentation in accordance with FDA and ISO standards.
• Design, execute and document experiences, equipment and process validations to
scale up and improve quality and efficiencies of manufacturing operations.
• Analyze and evaluate data, document findings, make and implement
recommendations supported by results.
• Train personnel cGMP, operational tasks, Manufacturing Operating Procedures
(MOP), Standard Operating Procedures (SOP) and safety policies.
• Develop and maintain departmental operating and capital budgets.
• Participate as integral member of Total Quality Management and Reengineering
teams to improve quality, systems and efficiencies.
• Revise the batch records, MOP, SOP, validation protocols and acceptance reports.
• Play an active roll in the development of employee’s careers.

Hitachi Chemical Diagnostics, Inc. – Mountain View , CA

01/16/99 – 01/05/00
Manufacturing Team Leader
• Package and assemble diagnostic test kit, dispense and cap reagents. Print and
apply labels and perform plastic welding operations according to cGMP, batch records,
MOP, SOP and safety policies.
• Perform line clearances, assign expiration dates and inspect components.
• Perform “Second check” to verify the Bill of Material and set up, and the
accuracy of label printing.
• Complete and review batch records, cleaning logs, and equipment use and
maintenance records.
• Help to coordinate daily production scheduling among work group.
• Perform Bill of Material accountabilities and transact work in process status in the
computerize inventory system.
• Perform standard preventive maintenance on laboratory equipment.
• Train personnel to perform essential job functions.
• Revise batch records, MOP and SOP.

Hitachi Chemical Diagnostics, Inc. - Mountain View, CA

01/16/97 – 01/15/99
Manufacturing Associate I, II & III

• Manufacture loomed pettes, bottled reagents and assembled kit according to

cGMP, batch record, MOP, SOP and safety policies.
• Set up and operate welder, dispensing equipment, capper and inkjet printer.
• Complete batch record accuracy and component accountability. Complete
cleaning log, equipment use log and maintenance record.
• Perform in process visual inspection of loomed pettes and bottled reagent and
judge quality based on visual criteria. Perform trimming, leak testing, and labeling of
pette bodies. Perform foil pouching of pettes.
• Perform dispensed reagent fill checks and capped reagent torque measurements.
• Perform verifications of manufacturing operations, line clearances, assign
expiration dates and inspect components.
• Ensure correct components issued to lot orders.
• Set up and operate of computer generated labels.
EDUCATION AND TRAINING

Cal State University of San Luis Obispo – Finished Junior year

De Anza College- Over 100 transferred units
Management/ Supervisory Training
Root Cause Analysis Training
Deming’s Concepts Training
Frontline Leadership Training
GMP and ISO training