Quality Assurance

22 hours ago

Kochi Kerala, India Careon Healthcare Solutions Pvt Ltd Full time

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

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