Mechanical Assembler
Resume:
Galen Lee
Medical Device Assembly
San Jose, CA *5121
*********@*****.***
+1 (408) 726 - 8195
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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
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