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Quality Assurance Officer

1 month ago

Kochi Kerala, India ubio Biotechnology Systems Pvt Ltd Full time

* **FEMALE CANDIDATES REQUIRED**
- 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’s degree in a scientific or technical discipline or equivalent experience
- Strong knowledge of ISO 13485 requirements and other relevant regulations and standards

Pay: From ₹12,000.00 per month

Schedule:

- Day shift
- Morning shift

Work Location: In person