The ideal candidate will need to have the following qualities and 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.

 

Our client, is actively searching for a QMS Engineer (Medical Devices) to join their team.

This role is a constructive step forward for anyone looking for excitement and challenges at work.

The responsibilities of this role encompasses:

• Participate in the development and implementation of quality initiatives to address QMS inadequacies as well as to achieve quality improvement objectives. Support Quality team in systems / product / process quality and compliance. 
• Coordinate with the various functions to ensure awareness and understanding of the Quality Management System. Drive, co-ordinate and work with cross functional 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.

 

An exciting career awaits the right candidate! Click "Quick Apply" to register your interest now.

All applicants' CV will be treated with the strictest confidentiality. We regret to inform that only shortlisted candidates will be contacted.