Salessense

Quality Technician-CAPA & NCR experience required

IE-Galway
3 weeks ago(11/30/2017 12:09 PM)
ID
2017-1414
# of Openings
1

Overview

The ideal candidate will be working in the manufacturing area providing real time QA support to the Production line. 
This will include the implementation of process controls, CAPA systems, and day to-day problem solving.
 

Qualifications

•Minimum of 2 years industry experience in a Medical Device Manufacturing environment and within a QA role.

•Educational Background in Science/Engineering/Quality is required

•Experience within a hands-on line support type role is highly desirable

•Good understanding of problem solving methodologies is required

•Excellent Computer Skills including (MS Word, Excel, PowerPoint and Access)

•Excellent communication (both verbal and written) & interpersonal skills

•Flexible, highly motivated individual

Responsibilities

•Provide hands-on line support to the catheter line, acting as a key member of the Line support team

•Work with the QE to actively implement the LMS systems

•Direct Involvement in continuous improvement projects and initiatives

•Maintenance of Quality metrics and reporting systems

•Preparation of Quality reports for Quality meetings and management reviews

•Provide support to the implementation of process controls and CAPA systems designed to meet or exceed internal and external requirements

•Act as an effective team member in supporting quality disciplines, decisions and practices

•Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues

•Ensure regulatory compliance to GMP for all medical device regulatory agencies

•Suggest  changes in procedures and standards  to facilitate work efficiency and maintain quality

•Reporting Functional area Quality Metrics

•Conduct internal Quality audits to ISO and GMP requirements

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