Quality Assurance (QA)/(RA) Specialist

BIOCHEETAH PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

A leading medical device company in Singapore is seeking a qualified individual to manage the Quality Management System in compliance with ISO 13485:2016. The ideal candidate will have a Bachelor of Science degree and at least 3 years of quality management experience in the medical device industry, focusing on design control and risk management. Strong communication skills and proficiency in MS Office are essential, while conversational Mandarin is preferred.

Qualifications

• Minimum of 3 years of ISO 13485 experience in the medical device industry.
• Strong verbal and written communication skills; conversational Mandarin preferred.
• Direct experience in design and development, and risk management of medical device products preferred.

Responsibilities

• Monitor and report on the adequacy of the Quality Management System.
• Promote awareness of medical device regulations and standards.
• Manage document control and engineering change control processes.
• Evaluate and monitor suppliers; maintain the Approved Supplier List.
• Manage the internal audit and calibration programs.
• Participate in design control, risk management, and software development activities.
• Handle non-conforming products and prepare premarket regulatory submissions.

Skills

Quality management system experience

Analytical skills

Time management

Organizational skills

Communication skills

Proficient in MS Office

Education

Bachelor of Science in chemistry, biochemistry, microbiology, or biomedical engineering

Job description

Responsibilities

• 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.