Principal Software Design Engineer (Medical)

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

Responsibilities:

• In charge of establishing the process and work in the team to implement risk management best practices in projects
• Implement and maintain the office's ISO 13485 and IEC 62304 compliant quality management system processes and procedures across departmental work and projects.
• Responsible in providing guidance and development support to the projects handled
• Taking charge of validating and advising project teams on regulatory, quality and risk requirements
• In charge of implementing and maintaining ISO 13485 and IEC 62304-compliant quality management system processes and procedures
• Responsible in
• In charge of managing project tasks which includes ensuring of timely completion of project milestones and meeting KPIs
• In charge of compliance with quality, regulatory and organisational policies and systems while supporting required record-keeping and documentation.

Requirements:

• Min Degree in Engineering /Science or relevant
• Min 2 years of working experience in QMS, Risk Management and design & development in medical industry
• Experience in ISO13485 /IEC62304 audit is required

To submit your application, please apply online to [e-mail] or call +(65) 6513 5697 for private and confidential discussion.

Your interest will be treated with the strictest of confidence. We regret that only shortlisted candidates will be notified or contacted.

RN Care Pte. Ltd
EA License No: 17C8900