Quality Assurance Officer

Year Kochi, Kerala, India

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* FEMALE CANDIDATES PREFERRED JOB DESCRIPTION

Maintain quality management systems that meet the requirements of ISO 13485 and other relevant regulations
Work with team, oversee internal audits to assess compliance with quality management systems, and identify areas for improvement
Manage non-conformances and corrective and preventive actions, ensuring timely and effective implementation of solutions
Coordinate and prepare for external audits, including regulatory agency inspections and customer audits
Guide employees on compliance issues, and ensure understanding of quality policies and procedures
Monitor and analyze quality metrics, and implement process improvements where necessary
Review and approve documentation, including Standard Operating Procedures (SOPs), work instructions, and quality records
Participate in the development and implementation of training programs for quality management systems
Keep up-to-date with changes in regulations and standards related to ISO 13485, and ensure compliance

EDUCATION

Bachelor\xe2\x80\x99s degree in a scientific or technical discipline or equivalent experience
Minimum of 2 years of experience in quality assurance. Prefer candidates with experience in IVD or medical device industry
Strong knowledge of ISO 13485 requirements and other relevant regulations and standards

Job Type: Full-time Pay: From 12,000.00 per month Schedule:

Work Location: In person

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