Senior/ Engineer, Quality & Regulatory - Medical Devices (Healthcare)
JOBSTUDIO PTE. LTD.
Singapore
Not specified
Bachelor degree in engineering or science
2-4 years experience in medical device industry
Knowledge of iso 13485 and iso 14971 standards
JobStudio PTE. LTD. is hiring a Senior Engineer in Quality & Regulatory for medical devices in Singapore. The role involves supporting risk management, maintaining quality systems, and collaborating across teams, requiring specific qualifications and experience in the medical device industry
Job Summary
The role involves supporting risk management activities and maintaining Quality Management Systems aligned with ISO 13485 and ISO 14971.
Candidates will collaborate with clinicians and engineering teams to validate requirements and support product de-risking initiatives.
The position requires preparing Design History Files, technical documentation, and contributing to grant submissions and innovation projects.
Matching Summary
Match Score: 75
JobStudio PTE. LTD. is hiring a Senior Engineer in Quality & Regulatory for medical devices in Singapore. The role involves supporting risk management, maintaining quality systems, and collaborating across teams, requiring specific qualifications and experience in the medical device industry.
Skills & Requirements
Must-have
Bachelor Degree in Engineering or Science
2-4 years experience in medical device industry
Knowledge of ISO 13485 and ISO 14971 standards
Nice-to-have
Experience with IEC 62304 software standard
Exposure to audit processes and documentation
Understanding of software development lifecycle
Key Requirements
Bachelor Degree in Engineering/Biomedical Engineering/Science
2-4 years working experience in regulated environments