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Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and approximately 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.
Job No: 154 CIC: Oliver Kau
(Reg. No: R1107246)
QA Engineer   EA License No: 07C3481
  Date Posted: 2015-09-29
 
Competencies
  • Bachelor of Science / Engineering
  • Minimum of 5 years of Quality Management System role in medical devices industry.
  • Proficient computer skills (MS Office).  Good verbal and written communication skills.
  • Must be detail oriented and able to work independently to meet the deadlines.
  • Good knowledge of ISO9001, ISO13485 and QSR21CFR regulations.
  • Certified ISO13485 Internal Auditor, Lead Auditor preferred.
  • Ability to present and communicate at all levels.
 
ResponsibiliTies

  • Coordinate with the various functions to ensure awareness and understanding of the Quality Management System. Drive, co-ordinate and work with cross funcational team to close the any QMS deficiency.

  • Organise ISO9001, ISO13485, ISO14791, QSR21CFR and GxP awareness training.

  • Coordinate external audit and internal audit by plan and drive for action plans and implementation.

  • Regularly update to Head of Quality on the progress of audit findings closure and corrective actions taken.

  • Participate in the construction of SOPs.

  • Drive continuous improvement projects on quality management system to meet the company goals, objectives, policies and procedures. 

  • Ensure timely and accurate completion of quality projects and tasks.

  • Coordinate CAPA and change control review and provide regular update and track effectiveness of CAPA and change control.

  • Ensure the quality systems and procedures are in compliance with ISO9001, ISO13485, ISO14791, QSR21CFR and OHSAS18001 requirements.
 
Experience
  • Bachelor of Science / Engineering
  • Minimum of 5 years of Quality Management System role in medical devices industry.
  • Proficient computer skills (MS Office).  Good verbal and written communication skills.
  • Must be detail oriented and able to work independently to meet the deadlines.
  • Good knowledge of ISO9001, ISO13485 and QSR21CFR regulations.
  • Certified ISO13485 Internal Auditor, Lead Auditor preferred.
  • Ability to present and communicate at all levels.
 
Salary
$4000 -- $5000 per Month
 
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