Qualification:

·         Bachelor’s/Master’s in Science or Diploma /B. Tech In Polymer Technology or any other Subjects.

·        Specialization in Biomedical or Quality preferred

Key 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 teams

·        Knowledge 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 efficiency

·        Proficient in tools such as 5S, Kaizen, and Root Cause Analysis to support continuous improvement

·        Internal Audits & Management Reviews

·        Document & Record Control

·        Customer Complaint & CAPA Handling

·        Supplier Quality Management

·        Risk Management

·        Training & Competency

·        Cleanroom & Environmental Monitoring

·        Post-Market Surveillance (PMS/PMCF/PSUR As per EU MDR)

·        QMS Change Control