Quality Assurance Executive
Madhu Instruments Pvt Ltd
Location
Delhi | India
Job description
Tips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall.
Responsibilities
- 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
Qualifications
B.Sc/ B.Tech
Work experience should be minimum 3-4 years in medical devices manufacturing.
Excellent computer skills
Goal Oriented
Strong communication skills, including the ability to explain and teach methodologies
Understanding of manufacturing methods and quality standards
A confident and determined approach
Excellent organizational & time management skills
Team player
Job tags
Salary
