• Serves as the Management Representative to monitor and report on the adequacy, effectiveness

and continuing suitability of the company's Quality Management System (QMS) in accordance

with ISO 13485:2016, established policies/procedures, and applicable regulatory requirements.

• Promote awareness of applicable, new and/or updated in-vitro diagnostic medical device

regulations and standards.

• Manage the document control, engineering change control, and records control process including

external origin documents.

• Evaluate, monitor, and re-evaluate suppliers. Maintain the Approved Supplier List (ASL).

• Manage the internal audit program to ensure timely execution in accordance with published

schedule.

• Manage the calibration program to ensure all monitoring and measuring equipment are inducted,

calibrated, reviewed, and monitored in a timely manner.

• Participate in design control, risk management, and software development activities throughout

the lifecycle(s) of medical devices at BioCheetah. Participate in risk assessment (FMEAs and SHA)

and risk control activities of device design, use, and manufacturing.

• Participate in the validation of analytical test methods, process validations, and computer

software used in the quality management system, production, and monitoring/testing.

• Participate in the handling of non-conforming products including but not limited to investigation,

corrective/preventive actions, and disposition of affected products.

• Participate in the preparation of premarket regulatory submissions for commercial distribution.

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, wiling to learn.

We regret that only shortlisted candidates will be notified.