Etsegenet Hailu

*** ******** **, *** **

Campbell, Ca 95008

408-***-****

ac73s1@r.postjobfree.com

OBJECTIVE: Seeking for a job the field of Quality Control

Inspection/ Quality Assurance /Receiving Inspection

SUMMARY OF QUALIFICATION:

7 years’ experience working with medical device in manufacturing setting

In Quality Control Inspection.

Experience with Drawing/Specification revision, tracking system,

Micrometer, Caliper, Snap gauges, Pin Gauges, measuring scope, Hand tools & wrenches, Micrometers, Rulers and tape measures, Dial thickness gauge, plug gauges, Surface height indicator, Digital and manual calipers, Optical comparator, Video inspection system, Microscope, Specialized jigs and fixtures, Micro Vu CMM (Coordinate Measuring Machine), Ultrasonic cleaners, Instron pull test equipment and Digital multi-function meters

Experience with GMP and ISO standards, Quick learner, team player and result driven

EXPERIENCE:

Quality Specialist IV

Abbott Vascular

4045 Campbell Ave, Menlo Park, CA 94025

May-2016 to Present

•Performs visual, dimensional and functional inspection and testing according to documented policies and procedures.

•Define, design, order, review, and implement as required all tooling, fixtures measuring equipment.

•Records inspection and test data as prescribed by written instructions and procedures.

•Operates all associated test and measurement equipment as instructed and as documented in procedures.

•Recommends changes to policies and procedures. May prepare and submit change requests.

•Documents non-conformances in Non-Conforming Material Review system.

•Participates in GR&R studies as directed by engineers or technicians.

•Collects data for First Article inspections.

•Performs testing and inspection in accordance with special test requests.

•Trains other Inspectors.

•Assists in gathering, analyzing, and trending of data.

•Performs work of a miscellaneous nature as required.

•Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

•Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

•Performs other related duties and responsibilities, on occasion, as assigned

•Performs general receiving inspection, in-process, and final inspection of product, packaging and labeling

•Conducts visual, dimensional and functional inspection, as directed by quality assurance procedures and other specifications.

•Performs physical testing such as packaging peel tests

•Ensures measurement, test and inspection equipment is calibrated and in good condition.

•Generates nonconformance report.

•Fills out, organizes, reviews, maintains and archives quality control records (4. 16).

•Employs statistical sampling techniques in routine inspection and testing activities. Performs other duties as required by the Quality Assurance Operations management

QC Inspector II / Quality Specialist II (IQC)

International Clinical Device MFG - Addis Ababa, Ethiopia

October 2008 – February 2016

Performs mechanical inspection to ensure all quality aspects of the job are met exactly.

Inspect raw materials, components, fabricated/manufactured parts & assemblies

First Piece/First Article, Receiving/incoming inspection, in-process, final inspection

Generates detail inspection and nonconformance reports as necessary.

Checks documents for accuracy and compliance to requirements

Read and interpret information from engineering drawings, travelers, specifications and other documents to generate a complete and precise inspection report/record

Strong organizational, problem solving and analytical skills, strong attention to detail.

Perform Quality Control Inspection in accordance with ISO14001,13485, 9001

Perform First Article inspections on various medical device parts

Perform all stages of Inspection Procedure including receiving, In-process, and final

Data entry for Non-Confirming Product Review Request

EDUCATION: 2004-2008 Addis Ababa Bole High

Addis Ababa, Ethiopia

High School Diploma/GED.

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