Quality Engineer, QMS

Talent Search Pte Ltd| Date Posted: 27-Aug-2020
EA Licence No: 05C5173|EA Personal Registration No: R1102641
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Job Nature:
Permanent
Position Level:
Experienced
Qualification:
Bachelor's / Honours

Job Description

European medical product manufacturing company

  • Accountable and ownership over suppliers implementation and maintenance of company's Quality Management Systems 
  • Handle and develop suppliers management in areas of qualification, supplier audits, continual assessments, engineering change and quality nonconformance issues
  • Seek continuous improvement in suppliers' process, policy and procedures.
  • Identify and set KPI metrics using reporting tools to fulfil standards and regulations
  • Work with internal stakeholders in supplier development in an effort to ensure procedures and specification compliance by suppliers
  • Perform suppliers audits, analyse and evaluate of supplier performance trends
  • Coordinate and facilitate all CAPA activities 
  • Assist in planning and executing both external and internal audits
  • Develop, update and maintain QMS training materials for suppliers

 

Requirement

  • Bachelor in Engineering or relevant qualification
  • At least 5 years of quality engineering experience in the medical device / components industry 
  • Experience in supplier quality management  
  • Understanding of Quality Management Systems, ISO 13485, ISO14971 standards and conformance is a prerequisites 
  • Professional ISO13485 auditor Certification 
  • Knowledge of SAP system 
  • Strong in documentation control and records 
  • Excellent time management, organizational, and problem-solving skills
  • Good communication with internal and external customers
Company Overview
Talent Search Pte Ltd