Job Title: Quality Engineer (CDSCO)
Experience: 4–5 Years
Salary: ₹50,000 – ₹60,000 per month
Location: Mira Road, Mumbai
Job Responsibilities:
- Ensure compliance with CDSCO, ISO, and regulatory requirements.
- Handle quality assurance and quality control activities across manufacturing processes.
- Prepare and maintain regulatory and quality documentation.
- Conduct internal audits and support external regulatory inspections.
- Investigate quality issues, customer complaints, and implement CAPA.
- Monitor product quality and ensure adherence to specifications and standards.
- Coordinate with Production, R&D, and Regulatory teams for quality compliance.
- Review batch records, validation documents, and quality reports.
- Support product registrations and regulatory submissions as required.
Skills Required:
- Strong knowledge of CDSCO regulations, ISO 13485, GMP, and quality systems.
- Experience in QA/QC within a manufacturing or medical device environment.
- Knowledge of CAPA, risk management, audits, and documentation control.
- Proficiency in MS Office and quality management systems.
- Strong analytical, problem-solving, and communication skills.
Preferred Industry: Medical Devices, Pharmaceuticals, Healthcare Products, or Regulated Manufacturing Industry.
Pay: ₹50,000.00 - ₹60,000.00 per month
Work Location: In person
