Junior QA Analyst - Medical Devices & Compliance

Arni Medica Pvt Ltd.; Hinoba-an; On-site; PHP 118,000 - 158,000; Full time

Job summary

Arni Medica is 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.

You will assist in implementing and maintaining QMS, review BMR/DHR, participate in audits, and help with SOPs, CAPA, and change control while ensuring ISO 13485 and GMP compliance.

Qualifications

• 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.

Responsibilities

• Assist in implementation and maintenance of Quality Management System (QMS).
• Support preparation, review, and control of SOPs, formats, and QA documents.
• 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

QA concepts

ISO 13485

Attention to detail

Documentation

Communication

Cleanroom

Job description

Arni Medica is 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.

You will assist in implementing and maintaining QMS, review BMR/DHR, participate in audits, and help with SOPs, CAPA, and change control while ensuring ISO 13485 and GMP compliance.