Your Task,
-Perform onsite audits at manufacturer’s premises by evaluating their Quality Management Systems in accordance with the requirements of ISO/EN ISO 13485, ISO 9001, EU MDR/IVDR, MDSAP and other schemes.
-Ensure, that audit is compliant to relevant internal procedures, standards and regulations.Draw up records and report on the corresponding audits.
-Keep up to date for relevant regulation and procedures.
-Collaboration with audit teams and stakeholders.
-Gather relevant objective evidence during audits by reviewing documentation, interviewing personnel and observing processes.
-Evaluate audit results to identify non-conformities, deviations, and areas for improvement, Compile comprehensive report, follow-up on corrective actions.
-Drawing clear conclusions from the audit and provide additional information as requested to support final review and certification decision-making.
-On-time completion of trainings and authorizations.
-Handle a group of clients and respective projects upto date and follow-up for audit planning.
-Handle client data confidentially and timely.
Your qualification,
Gradulation in biology or microbiology, chemistry or biochemistry, mechanical engineering or bioengineering, human physiology, medicine, pharmacy.
Minimum of four years of full-time work experience in the field of medical devices or related sectors (e.g., medical device industry, healthcare, medical device audit or research in medical devices)
Knowledge in Medical Device Quality Mangement System,
Knowledge in EU and International Regulations on Medical Devices,
Certification or Training (If any required),
Not Mandatory but prefered QMS LA on ISO 13485 or ISO 9001
Awareness program on EU / International Regulatory frame works on Medical Devices
Other trainings on risk management, including risk analysis, process validation, sterilization and related processes.
Four years work expereince in Design, Manufacturing, Application of the medical devices/Two years audit experience with medical device- ISO 13485:2016/MDR/MDSAP.