Senior Medical Software Quality & Risk Engineer

RN CARE PTE. LTD.; Serangoon Garden Circus; On-site; SGD 80,000 - 100,000; Full time

Job summary

A healthcare regulatory firm in Singapore is seeking a professional to implement and maintain quality management systems compliant with ISO 13485 and IEC 62304. The ideal candidate will have a degree in Engineering or Science, with at least 2 years of experience in QMS and risk management within the medical industry. This role involves establishing processes, providing guidance to project teams, and ensuring compliance with regulatory standards. Applications can be submitted via email or phone for confidential discussions.

Qualifications

• Min 2 years of experience in QMS, Risk Management in medical industry.
• Experience in ISO13485 / IEC62304 audit is required.

Responsibilities

• Establish processes for risk management best practices.
• Maintain ISO 13485 and IEC 62304 compliant quality management system.
• Guide projects on regulatory, quality, and risk requirements.
• Manage project tasks to ensure timely completion and meeting KPIs.

Skills

QMS implementation

Risk management

Quality assurance

Regulatory compliance

Education

Min Degree in Engineering / Science

Job description

A healthcare regulatory firm in Singapore is seeking a professional to implement and maintain quality management systems compliant with ISO 13485 and IEC 62304. The ideal candidate will have a degree in Engineering or Science, with at least 2 years of experience in QMS and risk management within the medical industry. This role involves establishing processes, providing guidance to project teams, and ensuring compliance with regulatory standards. Applications can be submitted via email or phone for confidential discussions.