Location: Kerala

Department: Quality Assurance

Experience: 8–10 years (with 3+ years in leadership) Medical Device Industry preferred

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

· Specialization in Biomedical or Quality preferred

· - 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