Quality Control Executive, Medical Devices

Position: Quality Control Executive

Department: Quality Control

Location: Santej, Ahmedabad

Job Purpose

The Quality Control Executive will be responsible for supporting day-to-day quality control activities for medical devices, including inspection, testing, documentation, maintenance of QC records, and compliance with applicable procedures and quality requirements.

Key Responsibilities

• Quality Control Activities
• Perform routine inspection and testing of incoming materials, in-process materials, and finished medical devices, as applicable.
• Carry out testing according to approved specifications, test methods, and SOPs.
• Record and review test results accurately.
• Microbiological / Laboratory Activities
• Perform applicable microbiological testing under defined procedures.
• Handle samples and laboratory materials appropriately.
• Maintain cleanliness and proper practices within the QC/laboratory area.
• Documentation
• Prepare and maintain QC test reports, worksheets, logbooks, and other records.
• Ensure records are complete, accurate, legible, and traceable.
• Follow Good Documentation Practices (GDP).
• Quality & Compliance
• Follow approved SOPs, work instructions, specifications, and quality procedures.
• Support investigation of deviations, non-conformities, and out-of-specification results, as applicable.
• Assist in CAPA and other quality improvement activities.
• Support compliance with applicable medical device quality and regulatory requirements.
• Equipment & Laboratory Management
• Perform routine checks of QC equipment.
• Support calibration and verification activities.
• Maintain equipment records and logbooks.
• Ensure laboratory equipment and work areas are maintained properly.
• Coordination
• Coordinate with QA, Production, R&D, and other departments for quality-related activities.
• Communicate test results and quality observations to the concerned personnel.
• Support internal and external audit activities when required.

Training & Development

For freshers, the employee will receive on-the-job training related to:

• Medical Device Quality Control
• QC testing and inspection
• SOPs and documentation practices
• Quality management systems
• Medical device regulatory requirements
• Deviation, non-conformity and CAPA processes
• Laboratory and QC equipment handling

Expected Competencies

• Attention to detail
• Good documentation skills
• Basic laboratory knowledge
• Ability to follow procedures
• Good communication and teamwork
• Willingness to learn
• Responsible and systematic approach to quality-related work

Qualifications

• Bachelor’s Degree in Life Sciences – including Pharmacy, Microbiology, or related fields.