Quality Data Entry
Resume:
Etsegenet Hailu
Campbell, Ca 95008
***********@*****.***
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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