Provide Quality and Compliance expertise to ensure system compliance with requirements.
Author and review the Validation Deliverables such as Validation Plan, Protocol and Summary reports. Provide and/or review protocols/reports / status / schedules of testing activity and results.
Prepare documentation as required by product development processes, Software Development Life Cycle processes in compliance with regulatory requirements, such as USFDA, ISO 13485 standards.
Work with other groups to follow issues to resolution.
Maintain and continuously develop IDC quality systems and infrastructure to ensure compliance and effectiveness
Liase with Quality Manager to monitor and report on the performance of the Quality Management System
Establish and drive successful fulfillment of Quality Management System
Responsible to send daily status reports and highlight risks as appropriate to the Management.
Liase with Management to support audits.
Qualification of the software for the validation labs in conjunction with the FSCs
Ensure compliance to organizational policies, procedures and regulatory requirements such as FDA, ISO 13485, ISO 14971
Knowledge on IVDR compliance
Establish and drive successful fulfillment of Quality Management System
Ensure compliance to organizational policies, procedures and regulatory requirements such as FDA, ISO 13485, ISO 14971
Provide Quality and Compliance expertise to ensure system compliance with requirements.
Prepare documentation as required by product development processes, Software Development Life Cycle processes in compliance with regulatory requirements, such as USFDA, ISO 13485 standards.
Maintain and continuously develop IDC quality systems and infrastructure to ensure compliance and effectiveness
Liase with Quality Manager to monitor and report on the performance of the Quality Management System.
Degree in sciences, life sciences, engineering or quality management or equivalent education gained through work experiences
5 years+ experience within the regulated environment
Extensive software development process experience or practical experience with product software verification and/or validation
Certified ISO13485, ISO14971
High level of autonomy and critical thinking is required. Teamwork oriented.
It would be a plus if you also possess previous experience in:
Certifications (ex: ISO27001 preferred)
Experience working with cloud services environment under regulations