JOB DETAILS

1) 5+ years of experience in quality assurance in medical device industry
2) Experience to ISO 13485:2003; ISO 9001:2000, US FDA, regulatory compliance preferred, injection molding, compression molding, sterilization, physical lab.
3) IPQA, Process validation, IQ,OQ,PQ activities.
4) Responsible for implementation of formats and control as per ISO13485 and ISO 9001.
5) Responsible for Internal Audit and implementation & Verification of ISO.
6) Responsible for shipment of Finished Goods for sterilization and Export.
7) Responsible for Supplier Qualification, Coordination and Quality.
8) Responsible for Validation of all lab equipments.
9) Clean Room audit and compliance. Work closely with Design and Development team to support the current product development Responsible for maintaining procedure for operation,



maintenance and calibration of all process equipment’s and laboratory equipment’s.
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📌 Asst Manager Ipqa Medical Device Industry Mumbai, Maharashtra, India 6lakhs Harshala 9029063330 Navi Mumbai
🏢 SEVEN CONSULTANCY
📍 India