Senior Software Development Engineer (Medical)

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
• 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

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