Key skills:
Thorough Knowledge of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017
Desired Candidate Profile
• Implementation and improvement in Quality Management System as per ISO 13485:2016.
• Implementation & Formation of Standard Operating Procedure (SOP) & Protocols as per GMP.
• Maintain complete documents of various departments like Site Master File, Device Master File with easy archival/retrieval.
• Involve onsite into the calibration & Validation activities. Preparation of Calibration calendar and preventive maintenance.
• Assist in preparation of Batch Manufacturing Record as per manufacturing and their review before release of the batch.
• Giving line clearance before starting the New Batch.
• Review and analysis of Environmental Monitoring plan to monitor environmental condition and hygiene of Personnel working in manufacturing areas and other controlled areas.
• Experience of CE, ISO 13485:2016 and GMP Inspections.
• Experience of Risk Management as per ISO 14971
• Experience of Design & development file as per ISO 13485:2016
• Knowledge of Post Market Surveillance and Post Market Clinical Follow Up, Product recall-
Handling and handling market complaints as per SOP and maintaining its records.
Education- UG: B Tech in Mechanical, BE – Bio Medical, B. Pharma, B. Tech Medical Science
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