Medical Device Quality Specialist

3 days ago

Singapore beBeeQualityManagement Full time $90,000 - $120,000
Quality Management Specialist

At our organization, we are seeking a highly skilled Quality Management Specialist to join our team. The ideal candidate will have a proven track record in quality management system implementation and maintenance.

The Responsibilities of this role include:
  • Serving as the management representative to monitor and report on the adequacy, effectiveness and continuing suitability of the quality management system in accordance with ISO 13485:2016, established policies/procedures, and applicable regulatory requirements.
  • Promoting awareness of applicable, new and/or updated in-vitro diagnostic medical device regulations and standards.
  • Managing the document control, engineering change control, and records control process including external origin documents.
  • Evaluating, monitoring, and re-evaluating suppliers. Maintaining the approved supplier list.
  • Managing the internal audit program to ensure timely execution in accordance with published schedule.
  • Managing the calibration program to ensure all monitoring and measuring equipment are inducted, calibrated, reviewed, and monitored in a timely manner.
  • Participating in design control, risk management, and software development activities throughout the lifecycle(s) of medical devices.
  • Participating in risk assessment (FMEAs and SHA) and risk control activities of device design, use, and manufacturing.
  • Participating in the validation of analytical test methods, process validations, and computer software used in the quality management system, production, and monitoring/testing.
  • Participating in the handling of non-conforming products including but not limited to investigation, corrective/preventive actions, and disposition of affected products.
  • Participating in the preparation of premarket regulatory submissions for commercial distribution.


Qualifications:

This is an excellent opportunity for a motivated individual who is looking to develop their skills in quality management. We offer a competitive salary package and opportunities for professional growth and development.

The Requirements for this role include:
  • Bachelor of Science degree in a scientific (chemistry, biochemistry, microbiology) or engineering (biomedical) discipline.
  • Minimum of 3 years of quality management system (ISO experience in the medical device industry. IVD experience is highly preferred.
  • Direct experience in design and development, and risk management of medical device products are strongly preferred.
  • Strong verbal and written communication skills. Conversational Mandarin is preferred.
  • Strong analytical, time management and organizational skills.
  • Proficient in MS Office applications.
  • Have a positive, proactive, can-do attitude, willing to learn.

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