Senior Medical Software Quality & Risk Lead

RN Care Pte. Ltd.

Singapore

On-site

SGD 60,000 - 100,000

Full time

4 days ago

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Job summary

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

Qualifications

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

Responsibilities

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