Bachelors or Masters in Biomedical Engineering and at least 2 years of experience in quality management system for medical device (ISO 13485).
Experience and skills
ï· A candidate should have hands on experience on implementing quality management system ISO 13485.
ï· Candidates must provide details of QMS projects handled.
ï· Knowledge of ISO and IEC standards such as ISO 13485, IEC 60601 standards
ï· Qualified internal auditor for ISO 13485
ï· Knowledge of Indian Medical device rule,2017.
ï· Fundamental understanding of product development process (for recent product development) which includes knowledge of hardware, software, mechanical and regulatory development activities amongst others
Roles and responsibilities
ï· Manage quality assurance procedure and records.
ï· Plan and guide various labs test for innovative medical device.
ï· Prepare and submit device dossiers to regulatory bodies as per client needs.
ï· Plan and conduct internal audits. Participate in the corrective and preventive action process.
ï· Imparting QMS training to new joinee.
ï· Identifying regulatory design input for design team.
ï· Identifying device related risk as per applicable regulatory requirements.
ï· Ensuring medical standard compliance - Studying the applicable product standards for medical devices, analysis of all applicable sections,
documenting the requirements and design aspects based on the study. Helping and tracking the implementation.
ï· Ensure design and test methodologies meets internal and external regulatory requirements
ï· Excellent understanding of product risk analysis and FMEA processes w.r.t corresponding medical standards (IEC 60601-1,IEC 60601-1-2, ISO 14971 etc).
ï· Detailed analysis of Software related risks and processes according to IEC 62304
ï· Detailed analysis of usability aspects of medical devices according to HFE 75, IEC 62366, IEC 60601-1-6, data security standards etc.
ï· Plan clinical trials for innovative medical dev