Quality Assurance

Job Description

1. Quality Assurance (QA) Manager Location: Kerala Department: Quality Assurance Experience: 8–10 years (with 3+ years in leadership) Medical Device Industry preferred 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 Job Types: Full-time, Permanent Pay: ₹40,000.00 - ₹55,000.00 per month Schedule: Day shift Work Location: In person