Qualification:Bachelors/Masters in Science or Diploma /B. Tech In Polymer Technology or any other Subjects.Specialization in Biomedical or Quality preferredKey Skills Required:- Strong knowledge of CDSCO(IMDR),ISO 13485:2016, ISO 14971, ISO 11135, GMP- Experience in CE MDR compliance, audits, and regulatory submissions- Capable of leading QMS, CAPA, and cross-functional quality teamsKnowledge of regulatory submissions and audits related to GCC countries (e.g., Saudi FDA, UAE MOHAP, SFDA, etc.), US FDA, and other European and African markets.Strong understanding of SEDEX platform and ethical audit compliance (SMETA 4-pillar)Experience in implementing Lean Manufacturing principles to enhance operational efficiencyProficient in tools such as 5S, Kaizen, and Root Cause Analysis to support continuous improvementInternal Audits & Management ReviewsDocument & Record ControlCustomer Complaint & CAPA HandlingSupplier Quality ManagementRisk ManagementTraining & CompetencyCleanroom & Environmental MonitoringPost-Market Surveillance (PMS/PMCF/PSUR As per EU MDR)QMS Change Control
