The Quality Control Executive is responsible for ensuring that medical devices meet established quality standards, regulatory requirements, and customer specifications. The role involves inspection, testing, documentation, and compliance with applicable national and international medical device regulations.
Key Responsibilities
- Perform incoming, in-process, and final inspection of medical devices and components.
- Conduct quality control testing and verification as per approved procedures and specifications.
- Prepare, review, and maintain quality records, inspection reports, and test documentation.
- Ensure compliance with applicable regulatory requirements including AERB, BIS, CDSCO, ISO 13485, and European Medical Device Regulations (EU MDR), as applicable.
- Monitor product quality and identify non-conformities; initiate corrective and preventive actions (CAPA).
- Support internal audits, external audits, customer audits, and regulatory inspections.
- Participate in root cause analysis and implementation of corrective actions for quality issues.
- Verify calibration status of measuring and testing equipment.
- Coordinate with Production, Quality Assurance, R&D, and Regulatory Affairs to resolve quality-related issues.
- Ensure compliance with Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs).
- Support validation, qualification, and process improvement activities.
- Maintain compliance with company quality management systems and applicable regulatory standards.
Required Qualifications
- Bachelor's degree or Diploma in Biomedical Engineering, Mechanical Engineering, Electronics, Biotechnology, Pharmacy, Life Sciences, or a related discipline.
- 2–5 years of experience in Quality Control within the medical device industry (experience may vary based on role level).
- Required Knowledge & Skills
- Strong knowledge of:
Preferred Certifications
- ISO 13485 Internal Auditor/Lead Auditor certification.
- Training in EU MDR, CDSCO Medical Device Rules, or related regulatory standards is preferred.
- Medical Device Regulations (India and Europe)
- AERB (Atomic Energy Regulatory Board) requirements (where applicable)
- BIS standards applicable to medical devices
- CDSCO Medical Device Rules, 2017 and related regulatory requirements
- ISO 13485:2016 Quality Management System for Medical Devices
- European Medical Device Regulation (EU MDR 2017/745)
- Understanding of risk management principles (ISO 14971 is desirable).
- Knowledge of inspection techniques, testing methods, and quality control tools.
- Familiarity with CAPA, non-conformance management, change control, and deviation handling.
- Experience with internal audits and regulatory compliance.
- Good analytical, problem-solving, and documentation skills.
- Proficiency in Microsoft Office and quality documentation systems.
Pay: ₹15,000.00 - ₹20,000.00 per month
Ability to commute/relocate:
- Thakur Pukur, Kolkata, West Bengal: Reliably commute or planning to relocate before starting work (Preferred)
Application Question(s):
- Should have knowledge of Medical Device Regulations
Experience:
- Quality control: 2 years (Preferred)
License/Certification:
Work Location: In person
