Madhu Instruments Looking for Quality Assurance Officer at New Delhi 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

Interested candidates can send their updated resume (hr at madhuinstruments.com) or can call 8130384348

Job Types: Permanent, Full-time

Salary: ₹50,000.00 – ₹60,000.00 per month

Benefits:

– Health insurance
– Provident Fund

Schedule:

– Day shift

Speak with the employer
+91 8130384348

▶️ Quality Assurance Officer
🖊️ Madhu Instruments
📍 New Delhi