Quality Assurance

1 day ago

Gautam Budh Nagar, India MEDISYS Full time

**Company Description**

MEDISYS (Premier Medical System and Devices Pvt Ltd) is India’s one of the oldest life saving medical devices manufacturing companies established in 1978. MEDISYS is one of the fastest growing Indian companies with its R&D Centre located in Noida, It has the technical capabilities and competent resources to research and develop high-end ICU equipment in a progressive frame work. MEDISYS has also provided the largest number of ventilators to the Indian Government during the COVID -19 pandemic.

This is a full-time role for a **Quality Assurance/Regulatory Affairs** at MEDISYS in Noida. As a **QA/RA** you will be responsible for ensuring quality management systems are implemented and maintained always and manage incoming inspection, quality assurance, and quality compliance.
- Develop, administer, and maintain quality assurance procedures and activities required to ensure that the company's processes and products comply with the medical device quality standards and requirements.
- Ensure that all manufacturing and packing operations carried out at the in-house manufacturing site comply with current good manufacturing practices desirable.
- Proper maintenance of control documents in Quality Assurance.
- Demonstrates an understanding of global standards, regulations, and regulatory bodies including but not limited to ISO13485.
- To handle all activities related quality management system, quality assurance & regulatory affairs for ISO 9001 & 13485, 93/42/EEC, WHO-GMP, EU MDR 2017/745,
IMDR 2017.
- Dealing in customer complaints, investigating, root cause analysis and replying, vigilance reporting & recall.
- Review & modification in all the SOPs & manuals.
- Review all data prior to submission to regulatory agencies for regulatory body audits.
- Coordinate and organize supplier audits, certification audits, customer audits, or other inspections. Execute and follow up on internal audit recommendations.
- Coordinate with R&D and manufacturing to develop validation protocol for production
process and generating the final report.
- Calibration of equipment and machines of production & quality control.

**Qualifications**
- Bachelor's degree in a relevant field (Quality Management, Engineering, etc.).
- Advanced degrees or relevant certifications are a plus.
- Proven experience of 4 - 6 years in quality assurance management, preferably in the medical devices manufacturing industry.
- Strong knowledge of quality management systems and regulatory requirements.
- Excellent problem-solving and analytical abilities.

Effective communication and interpersonal skills.

**Job Types**: Full-time, Permanent

**Education**:

- Bachelor's (required)

**Experience**:

- total work: 4 years (required)

Work Location: In person

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