QMS Lead: Medical Devices & Regulatory Compliance

CorDx; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A medical device company in Singapore is seeking a dedicated Quality Manager to develop and maintain their Quality Management System. The role involves ensuring compliance with local and international regulations, preparing for audits, conducting training, and investigating non-conformances. Candidates should have a bachelor's degree in a relevant field and at least 2 years of experience in quality management or regulatory affairs. Strong organizational and analytical skills are essential for success.

Qualifications

• Minimum of 2 years of experience in quality management or regulatory affairs.
• Familiarity with ISO 13485, GDPMDS, EU IVDR, and FDA QSR.
• ISO 13485 Lead Auditor certification preferred.

Responsibilities

• Develop and maintain the Quality Management System.
• Ensure compliance with regulatory requirements.
• Prepare and participate in audits and inspections.
• Conduct employee training on quality policies.
• Investigate non-conformances and implement corrective actions.

Skills

Quality management principles

Organizational skills

Analytical skills

Problem-solving skills

Communication skills

Education

Bachelor’s degree in Life Sciences, Biotechnology, Biomedical Engineering, or related field

Job description

A medical device company in Singapore is seeking a dedicated Quality Manager to develop and maintain their Quality Management System. The role involves ensuring compliance with local and international regulations, preparing for audits, conducting training, and investigating non-conformances. Candidates should have a bachelor's degree in a relevant field and at least 2 years of experience in quality management or regulatory affairs. Strong organizational and analytical skills are essential for success.