Jr QA Executive

Arni Medica is a leading medical device manufacturer specializing in contract manufacturing, new product development, and high-quality production of nephrology and healthcare products. We are seeking enthusiastic and detail-oriented fresh graduates to join our Quality Assurance (QA) team. This role provides exposure to quality systems, documentation, and regulatory compliance in a medical device manufacturing environment.

Requirements

• Assist in implementation and maintenance of Quality Management System (QMS).
  
• Support preparation, review, and control of SOPs, formats, and QA documents.
  
• Ensure Good Documentation Practices (GDP) across departments.
  
• Review Batch Manufacturing Records (BMR) and Device History Records (DHR).
  
• Assist in in-process quality assurance activities and line clearances.
  
• Support validation activities (IQ/OQ/PQ) and equipment qualification documentation.
  
• Participate in internal audits and assist during external audits (ISO 13485, GMP).
  
• Help in handling deviations, CAPA, and change control documentation.
  
• Ensure compliance with ISO 13485, GMP, and regulatory requirements.
  
• Maintain training records and assist in QA-related training programs.
  

Skills Requried:

• Basic knowledge of QA concepts and documentation practices
  
• Understanding of ISO 13485, GMP (basic level) is an advantage
  
• Strong attention to detail and willingness to learn
  
• Good documentation, analytical, and communication skills
  
• Ability to work in a regulated cleanroom and manufacturing environment