Quality Assurance Manager

6 days ago

Gurgaon, Haryana, India Genes2me Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Role & responsibilities

We are looking for a highly skilled QA professional with expertise in IVD medical devices. The role requires

strong knowledge of international regulatory compliance, audits, product registration, and documentation,

ensuring that our products meet the highest standards of quality and safety

Preferred candidate profile

  • Lead and manage audits (ISO:13485, CDSCO) and IVDR transitions.
  • Handle product registrations across multiple geographies (FDA, CE-IVDR, Thailand, Vietnam, Malaysia,

Saudi Arabia).

  • Prepare and compile technical documentation such as DMF, GSPR, Risk Assessments, SOPs, and

Labeling requirements.

  • Ensure compliance with regulatory standards in all product and process areas.
  • Demonstrate strong leadership, people management, and presentation skills.
  • Work with products such as Extraction Kits (Silica Column & Magnetic Beads) and RT PCR Kits (Infectious

disease, Cancer markers).

Qualifications

  • MSc in Biotechnology, Microbiology, Immunology (PhD is an advantage).
  • 710 years of Quality Assurance experience in an IVD medical device manufacturing environment.
  • Proficiency in MS Office and documentation management.

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