Medical Device Quality Assurance Specialist

2 days ago

Singapore beBeeQuality Full time $80,000 - $150,000
Medical Device Quality Assurance Professional

We are seeking a skilled Medical Device Quality Assurance Professional to join our team.

  • This is a pivotal role that involves monitoring and reporting on the adequacy, effectiveness, and continuing suitability of our Quality Management System (QMS) in accordance with ISO 13485:2016 established policies/procedures, and applicable regulatory requirements.
  • The ideal candidate will promote awareness of applicable, new, and/or updated in-vitro diagnostic medical device regulations and standards.
  • Key responsibilities include managing document control, engineering change control, and records control process including external origin documents.
  • Additionally, this position involves evaluating, monitoring, and re-evaluating suppliers. The successful candidate will maintain the Approved Supplier List (ASL).
  • Another key aspect of this role is managing the internal audit program to ensure timely execution in accordance with published schedule.
  • Responsibilities also include managing the calibration program to ensure all monitoring and measuring equipment are inducted, calibrated, reviewed, and monitored in a timely manner.
  • As part of the team, you will participate in design control, risk management, and software development activities throughout the lifecycle(s) of medical devices at our company.
  • Participate in risk assessment (FMEAs and SHA) and risk control activities of device design, use, and manufacturing.
  • Furthermore, this position requires participating in the validation of analytical test methods, process validations, and computer software used in the quality management system, production, and monitoring/testing.
  • Key responsibilities also include participating in the handling of non-conforming products including but not limited to investigation, corrective/preventive actions, and disposition of affected products.
  • Lastly, you will participate in the preparation of premarket regulatory submissions for commercial distribution.
Required Skills and Qualifications:
  • Bachelor of Science degree in a scientific (chemistry, biochemistry, microbiology) or engineering (biomedical) discipline.
  • Minimum of 3 years of quality management system (ISO 13485) 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.
Benefits:

As a valued member of our team, you will have the opportunity to grow professionally and contribute to the success of our company.

Others:

Please note that we do not discriminate based on race, gender, age, religion, national origin, disability status, or any other protected characteristic. We offer competitive compensation packages and benefits.

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