Company Profile: leading manufacturer and exporter of Surgical Gloves
Location:Cochin
Qualification:Bachelor in Science & preferably Diploma in Polymer Technology.
Experience:5 + year in latex based medical devices or gloves.
Job Responsibilities :
• Establishing & Maintaining QMS applicable to medical devices
• Liaising with all regulatory bodies related to Quality & with testing lab & with external audit agencies.
• Conducting validations of various processes in glove manufacturing, equipment qualification (IQ, OQ & PQ). Real time study, Stability study, Technical file for CE marking
• Approval of new vendors based on vendor evaluation.
• Preparing tender documents on request from Marketing dept & customers
• Co-coordinating & planning with Production, commercial & utilities.
Essential Skills:
• Competencies on ISO 13485, USFDA, BIS regulations
• QMS process validation, Risk analysis
• Raw material specification on rubber compound, sampling plan, Statistical Process control & finished product testing specifications & test methods.
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