Galen Lee

Medical Device Assembly

San Jose, CA *5121

adsu4g@r.postjobfree.com

+1 (408) 726 - 8195

(((RESUME)))

**/**** - ***

In searching for new job.

**/**** - **/****

TECAN System Corporation

Job Title:

Assembly Technician

Quality Assurance (Final Product)

Production Supervisor

Production Manager

Job Duties:

Assembly the robot arm system used for chemical mixing following MPI and SOP.

Check and verify the product, program, system, labels, date and signatures of

employees.

Supervise a number of assemblers:

Check on the product qualities

Report on quantities and qualities Pass/Fail

Report and record NCMR and analysis for each

Record FPY (First Product Yield) and FPY (Final Product Yield) document percentage and analysis

Sketch the graph (Employee Performance Activity Graph) and analysis each section of productivity based on calculating Quantity of Product/Time(minutes)

Promotion employees interview

Verify employees protocol check up

Verify FDA regulations, SOP, MIP, Blue Prints, BOM, Kit, Software, Labels, Employees’ signature, Date and Time.

Meeting with Engineer, QA Manager and Director for the production problems, analyze the problem and find down solutions.

Received and audit products return

Training employees

Calculate labor and bring up gross manufacturing product(GMP) rated up quality and quantity

Followed FDA and SOP, ISO 9000, 9001

Issue CAPA on some workmanship and revision.

08/2012 – 03/2014

Connor pharmaceutical Inc.

Job Title:

Scientist Formulation I

Job Duties:

Innovation the type of drug.

Set up project

Invent formulate

Developing the formulation

Testing the drug formulation in animals on the lab field

Observe the result and record the drug affects & reactions

Record Pass/Fail to Production Engineer Manager

Submitting the invention to the director and vice president

Display and explain the new type of drug to director board

If been approve by vice president, director, engineer and production manager.

I will fill out the innovation form with signatures approval from the vice president and director, engineer and production manager. The company will submit the innovation form to National Pharmaceutical Department & FDA and wait for the reply.

08/1997 – 07/2012

AMTEK Electronic Inc.

Title of Job:

Electronic Assembler, Material Handler, Stock Clerk, QC, Supervisor.

Duties of Job:

Read Blue Prints and BOM

Follow Blue Prints, and MPI to install IC, Resistor

Assembly the boards

Hand Load

Identify IC, resistors, boards

Fill out the check list received from production leader

Bring IC and resistors with other board materials to production line

Verify and Sign off Line Clearance

Count the IC and resistor, boards and record the # remaining in stock room.

Calculating # of boards, IC, resistors have been used for production

List and state the number of boards, IC, resistors Pass/Fail

and the type of reject and number of rejects.

Do the data entry to order the parts, boards IC and resistors.

Supervise 30 crews

Set up bench and equipment

Use Magnified glass and Microscope to inspect component,

IC resistors, inspect chassis and boards.

Training and promoting employees.

Meeting with engineers, manager for quality products

Set up employees work schedule and project deadline.

01/1995 – 07/1997

Boston Scientific Corp

Job Title:

Quality Assurance (Incoming & Final)

Test Technician

Assembly Technician

Job Duties:

Check and verify incoming raw materials.

Inspect final products verify and report Pass/Fail.

Use electronic box and prongs to test the catheter.

Assembly parts and subassembly parts following MPI and SOP plus blue print.

01/1993 – 01/1995

Electrophysiology Technologies Inc.

Job Title:

Assembly Technician

Quality Control Inspector

Job Duties:

Assembly epoxy at the tip of catheter following instruction of SOP.

Use the hot box to dry the tip and sculpture the epoxy ring under microscope.

Apply sense of fingers to detect the problem on the braid.

Determine Pass/Fail with analytical report, date and sign.

01/1990 – 12/1992

Disc copy Lab

Job Title:

Labeling

Packaging

Job Duties:

Apply adhesive label on the product.

Check and verify names, types, models #, parts #, and dimension of products.

Check paper work and documents according to procedure of MPI and SOP.

Sterilize and packing the product into the box.

Supply instruction booklet and company address at the left corner of the box.

01/1985 – 12/1989

Pyramid Precision Company

Job Title:

Security Officer

Job Duties:

Patrol around parking lot

Check the employee enter the gate

Check all cars make sure they not park in wrong parking

Report any irregularity activity

Receive & Answer the out coming and incoming phone at the lobby

Check on employees at back exit at the end of their day shift

Issue the visitor passing badge when clients visiting.

Call and notify or inform employees when necessary

Watch the monitor and report the outcome

Settle the dispute between employees

Contact the police in severe situation

Issue an amber alert in critical situation as: Fire, Chemical Exposure, Earthquake.

Skill:

Security officer experiences

Clean room experiences

Medical device experiences

Knowledge: ISO, SOP, MPI, CAPA, BOM, MRB, MHR, BLUE PRINT, NON CONFORMANCE ISSUE, FPY, Final PY, Employees Performance Rate, PDA.

Microscope experiences

Computer word processor experiences

Data entry experiences

Communication experiences

Electro-mechanical experiences

Assembly experiences

Scientist Formulation I

Quality incoming and final inspecting experiences

Quality analysis experiences

Quality auditor experiences

Nonconformance issue experiences

Labeling experiences

Packaging experiences

Caliper, micro-devices, meter, stick, hot box, magnetic resonance weld

Solder spring experiences

Laser welding experiences

Education:

High School Diploma

San Jose City College A.A. Degree

B.S. degree in Nutritional Science

B.S. degree in Quality management and Production management.

Authorized to work in the US for any employer

Contact this candidate