Senior Software Development Engineer (Medical)

RN Care Pte. Ltd.; Singapore; Presencial; SGD 60.000 - 100.000; Jornada completa

Descripción de la vacante

RN Care Pte. Ltd. is seeking a qualified professional to lead risk management for medical device projects in Singapore.

The role focuses on establishing and maintaining ISO 13485 and IEC 62304 compliant QMS processes across departments, guiding project teams, and ensuring adherence to regulatory and quality requirements. The ideal candidate brings at least 2 years of experience in QMS, risk management and design and development within the medical industry, with hands-on audit exposure to

Formación

• 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

Responsabilidades

• Establish and implement risk management practices for projects
• Maintain ISO 13485 and IEC 62304 compliant QMS processes across departments
• Provide guidance and development support to project teams
• Validate regulatory, quality and risk requirements for projects
• Implement and maintain ISO 13485 and IEC 62304 compliant processes
• Manage project tasks to ensure milestones and KPIs are met
• Ensure compliance with quality, regulatory and organisational policies and documentation

Conocimientos

Risk management

QMS

Regulatory compliance

Design & development

ISO13485

IEC62304

Project guidance

Documentation

Educación

Bachelor's degree in Engineering/Science

Descripción del empleo

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

RN Care Pte. Ltd
EA License No: 17C8900