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
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