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 solid 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