We are looking for a Quality Assurance & Regulatory Affairs (QARA) professional with 1–3 years of experience in the medical device industry. The candidate will support the maintenance of the Quality Management System (QMS), regulatory documentation, technical documentation, and compliance activities in accordance with applicable regulatory requirements and standards.
Key Responsibilities
Quality Management System (QMS)
Maintain and support the company’s Quality Management System in compliance with International Organization for Standardization 13485 requirements.
Prepare, review, update, and maintain QMS documents including SOPs, procedures, work instructions, forms, and templates.
Ensure proper document and record control practices, including version control, traceability, archival, and obsolescence management.
Perform document release checks and proofreading before release to ensure correct document numbering, revision status, formatting, and completeness.
Support handling and closure of Customer Complaints, CAPA, NCR, deviations, change controls, and risk management activities.
Monitor QMS performance metrics and support continuous quality improvement initiatives.
Coordinate internal training activities along with HR and ensure training records are maintained.
Coordinate with cross-functional teams to ensure completion and maintenance of quality records.
Support internal audit and external audit activities.
Bachelor’s degree in Engineering, Life Sciences, Biomedical, Pharmacy, Biotechnology, or related field.
1–3 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
Mandatory experience working with International Organization for Standardization 13485 Quality Management Systems.
Good understanding of document control, CAPA, NCR, complaint handling, and risk management processes.
Experience in technical documentation and QMS documentation management.
Experience in internal and external audit activities.
Good communication and coordination skills.
