Quality Control Manager(Manufacturing/Product Industry)

3 days ago

Gurgaon, Haryana, India Genes2me Full time ₹ 12,00,000 - ₹ 36,00,000 per year

About the Role

We are seeking an experienced Quality Control professional from the Medical Molecular Diagnostics Manufacturing and Product Industry to ensure the highest quality and reliability of our IVD medical devices. The role involves hands-on laboratory testing, validation, stability studies, and supporting product development through robust quality control measures in compliance with regulatory standards (including IVDR CE Marking).

Key Responsibilities & Skills

  • Perform hands-on testing and validation using RT-PCR, Spectrophotometer, pH Meter, Automatic Extraction Systems, and Gel Electrophoresis.
  • Ensure rigorous quality control processes across all IVD products.
  • Lead quality checks for Extraction Kits (Silica Column & Magnetic Beads) and RT-PCR Kits (Infectious Diseases, Cancer Markers, etc.).
  • Develop and maintain Standard Operating Procedures (SOPs) and ensure adherence to quality standards.
  • Prepare stability study documentation and manage clinical sample panels.
  • Handle complaints, perform troubleshooting, and provide mentorship to team members on OOS (Out of Specification) results.
  • Conduct calibration and validation of instruments and equipment.
  • Manage audit and documentation activities and support regulatory registration documents for overseas markets.
  • Drive continuous improvement in QC methodologies and systems.
  • Demonstrate strong leadership, people management, and presentation skills.
  • Ensure technical accuracy in IFU (Instructions for Use) documents, including intended use, principles, references, and procedures.

Qualifications

  • M.Sc. in Biotechnology, Microbiology, or Immunology (Ph.D. preferred).
  • 7–10 years of Quality Control experience in an IVD medical device manufacturing environment.
  • Strong knowledge of IVDR (CE Marking) reference standards and compliance requirements.
  • Proficient in MS Office and laboratory data management systems.
  • Minimum 7–8 years of experience with the ability to lead an existing QC team effectively.

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