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Medical Device Quality

Location:
San Jose, California, United States
Posted:
April 15, 2019

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Resume:

Thanh Nguyen

San Jose, CA

Cell Phone: 408-***-****

Email: ac83sn@r.postjobfree.com

Objective

With about 10years experience working on Medical Device field and laboratory environments. Organized and responsible team player who works effectively in fast-paced high-pressure situations, consistently producing high quality work and meeting deadlines.Ability to take on new projects and complete them with little or no supervision.Ability to adapt to changing needs and capable of handling multiple assignments.Understand the 5S and FDA regulation. Help engineers with collecting data and manufacturing process improvement.

Qualifications:

The ability to work with and inspect very small part and Sub-Assembly

Knowledge ISO 13485, GMP for Quality Management System Documentation.

Used Agile, Master Control system for documents control

Used system SAP, QAD, Epicor system for transfer parts

GD&T basic

Hands-on CMM, Micro-Vu, Vision System, Optical Comparator, Beta Laser Mike, Radius Gage, Digital Calipers, Micrometer, Indicator, Snap Gauges, Height Gauge; Drop Gauge, Thread gauge, Olympus Camera Microscope 500X, Calibrated Thermocouple, Microscope Reticle, Measurement Tools

Knowledge of using Office Applications such as Word, Excel and Power Point

Experience

COMET ( San jose) 06 /2017 - present

Quality AssuranceTechnician (FR Subsystem machine)

Inspect FAI

incoming inspection for metal, plastic parts, PCB for build RF Machine

Final inspection

Review DHR for products release

Provide technical quality supportto Manufacturing & Engineering as needed

Communicates inspection results to manufacturing and other departments, vendor and serves as a technical inspector

The Identification of issues and initiation of actions to prevent and occurrence of any nonconformity relating to products, processes, and the quality system as applicable to responsibilities outlined with this job description

Open NCR when need and follow process when disposition completed

Used SAP system to transfer parts

( Company have major issue from last can not solve, lose customer’s order, business goes down, laid off 70 % MFG area )

EARGO INC

Quality Assurance Specialist ( Hearing Device ) 2015 – 2016

Incoming inspection

FAI

In Process inspection

Open NCR when need and follow process when disposition completed

Perform Device History Records review for products release.

Audit DHRs, LHR maintained files for DHRs and update DHR log on daily basis

Interface with Production Management to coordinate inspection priorities

Communicate all quality issues to management in a timely manner

Capable of managing multiple tasks in a high paced environment with shipping priorities.

Provide technical quality supportto Manufacturing & Engineering as needed

Communicates inspection results to manufacturing and other departments and serves as a technical inspector to manufacturing and other departments for specific issues and requests.

Complete various forms and documentation as related to reporting inspection results.

Used QAD system to transfer parts

Can not find investor, no more more . Laid off 90% employees )

INTUITIVE SURGICAL( Sunnyvale, ca ) 2014 – 2015

IQC for Medical Device (Robotic Surgical Systems)

Incoming inspection and FAI for Mechanical parts

Review DHR for products release

Reports all processes and product non-conformances.

Maintains all required logs and records

Complete various forms and documentation as related to reporting inspection results.

Organize, file, maintain all inspection documents

Used system SAP to transfer parts

( Got laid off )

Thoratec (Sunnyvale, CA) 2014- 2014

QA for Medical Device ( Catheter Device )

First Article Inspection

Incoming inspection

Complete various forms and documentation as related to reporting inspection results.

Provide technical quality supportto Manufacturing & Engineering as needed

Assist R & D build catheter for new project

Ensures all issues/documentation associated with each process in assigned area have been resolved and approved prior to release to the next step and are compliant with GMPs and SOPs and current manufacturing regulations and site procedures. Analyzes and reports findings to appropriate departments.

( Company going to sell. Leave to get the other opportunity )

C8 Medisensors (Start – up in San Jose, CA) 2011-2013

IQC for Medical Device (Glucose Device)

Perform In-Process, Final inspection

Complete various forms and documentation as related to reporting inspection results.

Reports all processes and product non-conformances( NCR)

Maintains all required logs and records.

Track Preventive maintenance and Calibration due dates

Document review, editing and creation.

Collect data for Engineer

Manufacturing process improvement.

Perform status update and/accrual data for monthly, quarterly and manual reports

Used QAD system to transfer parts

(Bankrupcy )

ACCLARENCE ( Menplo Park ) 2008 to 2010

IQC for Medical Device ( Catheter Device)

Follow MPI perform Inspection in- process and final inspection for Balloon Catheter such as

Hypotupe& Label Bonding

Balloon Marker Band

Balloon Bonding

Tipping &Transition Fillets

Leak Test

Final Inspection

( Got laid off because J&J bough Acclarence )

EDUCATION

1992-1996 Administration Business Bachelor’s degree in Viet Nam

1988-1992 High School Diploma in Viet Nam



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