QA Specialist: Medical Devices, ISO 13485 Expert

BIOCHEETAH PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading medical device company in Singapore is seeking a Quality Manager to oversee and enhance the Quality Management System in compliance with ISO 13485 standards. You will be responsible for evaluating suppliers, managing audits, and ensuring regulatory compliance for medical devices. The ideal candidate has a Bachelor of Science degree in a relevant field and a minimum of 3 years of quality management experience specifically in the medical device industry, preferably with in-vitro diagnostics experience. This position requires strong analytical and communication skills.

Qualifications

• Minimum of 3 years of ISO 13485 quality management experience in medical device industry.
• Direct experience in design and development of medical device products preferred.
• IVD (in-vitro diagnostic) experience is highly preferred.

Responsibilities

• Monitor adequacy and effectiveness of the Quality Management System (QMS).
• Manage supplier evaluations and maintain the Approved Supplier List (ASL).
• Handle non-conforming products and participate in regulatory submissions.

Skills

Strong verbal and written communication skills

Strong analytical skills

Strong time management skills

Organizational skills

Conversational Mandarin

Education

Bachelor of Science in a scientific or engineering discipline

Tools

MS Office applications

Job description

A leading medical device company in Singapore is seeking a Quality Manager to oversee and enhance the Quality Management System in compliance with ISO 13485 standards. You will be responsible for evaluating suppliers, managing audits, and ensuring regulatory compliance for medical devices. The ideal candidate has a Bachelor of Science degree in a relevant field and a minimum of 3 years of quality management experience specifically in the medical device industry, preferably with in-vitro diagnostics experience. This position requires strong analytical and communication skills.