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