Quality Assurance Specialist

Requisition ID
2017-3135
# of Openings
1
Job Location(s)
Singapore Singapore
Travel
10-20%
Education
Bachelor's Degree
Position Type
Full Time
Expiry Date
30-11-2017
Category
Quality

Overview

Support QA Manager in the implementation and maintenance of Quality Management System in Singapore in accordance to ISO 13485.

Responsibilities

  • Assist to develop and maintain Quality Management System in compliance with ISO 13485.
  • Responsible for document control, change control, training management.
  • Assist QA Manager and Management in preparation of materials and follow up actions for Management Review.
  • Responsible to monitor and ensure activities required for maintenance of QMS are performed, including for risk management, supplier management and internal audits.
  • Assist in Livelink and Learning Management System (LMS) in Singapore.
  • Develop documentation system, and maintain controls and documentation procedures.
  • Perform training of Quality documents.
  • Perform qualification, verification or User Acceptance Tests of software or changes to software.
  • Analyse data to identify areas for improvement in quality system.
  • Investigate Customer complaint and non-conformance issues and monitor to ensure closure.
  • Coordinate the Corrective and Preventive Action (CAPA) system and monitor to ensure timely closure.
  • Perform internal audits and follow up with departments on CAPAs.
  • Participate in and monitor Risk Management activities related to SADC processes and software.
  • Verify and document any defects found during inspection of products and liaison with Cook Manufacturers.
  • Perform any product recalls from APAC countries with Cook distribution.
  • Perform supplier qualification, audit, corrective action request and improvement.
  • Perform as back-up for QC inspection and other duties.
  • Perform duties related to QMS based on Singapore Customs requirements.

Qualifications

  • 2- 5 years’ experience in Quality Assurance in a medical device or equivalent field.
  • Resourceful and possess initiative, and a thinking mindset.
  • Ability to multi-task.

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