Quality Assurance Specialist: ISO 13485 & Regs

BIOCHEETAH PTE. LTD.; Singapore; On-site; SGD 50,000 - 70,000; Full time

Job summary

A leading medical device company in Singapore is seeking a Quality Management Representative to oversee the effectiveness of the Quality Management System. The ideal candidate will have a Bachelor's degree in a scientific discipline and at least 3 years of ISO 13485 experience. Responsibilities include managing internal audits, supplier evaluations, and regulatory submissions. Strong analytical and communication skills are essential, and conversational Mandarin is preferred. Only shortlisted candidates will be notified.

Qualifications

• Minimum of 3 years of quality management system experience in the medical device industry
• Direct experience in design and development and risk management of medical device products preferred
• IVD experience is highly preferred

Responsibilities

• Monitor and report on the adequacy of the company’s Quality Management System according to ISO 13485:2016
• Manage document control and engineering change control processes
• Evaluate and monitor suppliers, maintaining the Approved Supplier List

Skills

Quality management system experience

Analytical skills

Time management

Organizational skills

Strong verbal and written communication

Conversational Mandarin

Education

Bachelor of Science in Chemistry, Biochemistry, Microbiology or Biomedical Engineering

Tools

MS Office

Job description

A leading medical device company in Singapore is seeking a Quality Management Representative to oversee the effectiveness of the Quality Management System. The ideal candidate will have a Bachelor's degree in a scientific discipline and at least 3 years of ISO 13485 experience. Responsibilities include managing internal audits, supplier evaluations, and regulatory submissions. Strong analytical and communication skills are essential, and conversational Mandarin is preferred. Only shortlisted candidates will be notified.