క్వాలిటీ మేనేజర్

Key Responsibilities

Quality Management System (QMS)

Implement, maintain, and improve QMS• in compliance with ISO 13485, •IVD regulations•, and applicable medical device standards.

• Ensure documentation control, SOPs, change control, deviations, CAPA, and risk management.

• Conduct internal audits and support external audits.

Regulatory & Licensing

Prepare, review, and submit licensing dossiers• for:

• Rapid Diagnostic Tests

• ELISA / Serology kits

• Medical Devices / IVDs

Handle product registration and renewals• with regulatory authorities such as:

• CDSCO / DCGI (India)

• CE marking

• WHO PQ (preferred)

• Other global regulatory bodies (as applicable)

• Coordinate responses to regulatory queries and deficiencies.

Compliance & Validation

Ensure compliance with GMP, GLP, GDP• where applicable.

• Review and approve validation documents (process, method, cleaning, stability).

• Oversee batch release and quality review for finished products.

Vendor & Change Management

• Qualify and audit vendors and suppliers.

• Manage product and process change controls related to regulatory impact.

Cross-Functional Support

• Work closely with R&D, Manufacturing, Regulatory Affairs, and Supply Chain teams.

• Support product development from a QA and regulatory compliance perspective.

Required Qualifications

Bachelor’s / Master’s degree in Biotechnology, Microbiology, Biomedical Engineering, Pharmacy, or Life Sciences•.

Formal training in ISO 13485 / QMS• preferred.

Required Experience & Skills

• Hands-on QA experience in Rapid tests, ELISA, or IVD medical devices.

• Proven experience in regulatory licensing and product registration.

Strong knowledge of medical device regulations and standards•.

Experience facing regulatory audits and inspections•.

• Excellent documentation, communication, and analytical skills.

• It is a Full Time ల్యాబ్ సాంకేతిక నిపుణుడు job for candidates with 4 - 6 years of experience.