Job Title: Sr. QA/QC Executive
Experienced in Medical Disposables Category only

Department: Quality Assurance / Quality Control
Reports To: Director
Location: Manufacturing Facility (Kathwada GIDC, Ahmedabad, Gujarat)

Job Purpose
To ensure that all products, processes, and systems comply with applicable quality standards, regulatory requirements, and internal procedures, ISO 13485, with a robust focus on medical devices, sterile products, and GMP compliance.

Key Responsibilities
Quality Assurance (QA)
Ensure implementation and compliance with QMS as per ISO 13485, ISO 9001, and GMP requirements.
Prepare, review, and control SOPs, formats, work instructions, and records.
Coordinate and support internal audits, external audits, and regulatory inspections.
Handle non-conformances (NCs), deviations, CAPA, and change control.
Ensure proper documentation for ETO sterilization cycles, validation, and release records.




Review batch manufacturing records (BMR), device history records (DHR), and sterilization logs.
Quality Control (QC)
Perform incoming, in-process, and final inspection of raw materials, semi-finished, and finished goods.
Ensure compliance of products with approved specifications and drawings.
Conduct visual, dimensional, and functional checks as applicable.
Maintain inspection records and ensure proper identification and traceability of materials.
Compliance & Documentation
Ensure compliance with Medical Device Rules (MDR), CDSCO, and customer-specific requirements.
Monitor calibration status of measuring instruments.
Ensure proper handling, storage, and segregation of accepted, rejected, and quarantine materials.
Support product release and dispatch approvals.

📌 Senior Executive Quality Assurance (Ahmedabad)
🏢 MEDRESS® l Cortex Products Solution
📍 Ahmedabad