Senior QA Engineer (Medical)

RN CARE PTE. LTD.; Serangoon Garden Circus; On-site; SGD 60,000 - 80,000; Full time

Job summary

A medical technology company in Singapore is seeking a qualified professional to establish and implement risk management practices while maintaining ISO 13485 and IEC 62304 compliant processes. The ideal candidate will have at least 2 years of experience in the medical industry focusing on quality management systems and risk management. Strong regulatory knowledge is crucial for guiding project teams and ensuring compliance during project execution.

Qualifications

• Min 2 years of working experience in QMS, Risk Management and design & development in the medical industry.
• Experience in ISO 13485 / IEC 62304 audit is required.

Responsibilities

• Establish and implement risk management best practices.
• Maintain ISO 13485 and IEC 62304 compliant quality management system.
• Guide project teams on regulatory, quality and risk requirements.
• Ensure timely completion of project milestones and meet KPIs.

Skills

QMS knowledge

Risk Management

Regulatory compliance

Education

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