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Quality Assurance Officer

2 weeks ago

New Delhi, India Madhu Instruments Full time

To handle all activities related quality management system, Quality Assurance & regulatory affairs for ISO 9001 & 13485, 93/42/EEC Directive including
- Technical files making & updating including risk management, clinical evaluation, post market surveillance, quality plan, ESRs, etc.
- Fulfilment of regulatory requirements related to EC directive, various Govt. tenders & registration of overseas.
- Follow up of local regulatory & drugs requirements.
- Validation
- machines, processes, clean rooms, material & sterilization.
- Organizing internal & external audits including notified bodies audits related to quality management system & CE and follow up of non-closure reports.
- Dealing in customer complaints, investigating, root cause analysis and replying, vigilance reporting & recall.
- MRM- Organizing & follow up actions from previous meetings.
- Review & modification in all the SOPs & manuals.
- Master list of records
- Establishment & updating.
- Master list of documents
- Establishment & updating.
- Deviations
- Follow up & records
- Corrective & preventive actions
- Corrections, implementations & maintenance.
- Calibration of equipment and machines of production & quality control.
- Handling out the pre-dispatch inspections of shipments by the outside agencies and certification bodies.
- Training
- Planning & Imparting

**Requirements**:

- Work experience should be minimum 15-20 years in a medical device manufacturing organization.
- Excellent computer skills, including MS Office
- Strong communication skills, including the ability to explain and teach methodologies
- Understanding of manufacturing methods and quality standards
- Good at math and statistics
- Strong problem-solving skills
- A confident and determined approach
- Excellent organizational & time management skills
- Team player

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

**Salary**: ₹50,000.00 - ₹60,000.00 per month

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift

**Speak with the employer**
+91 8130384348