QA/QC (medical devices)
Bhargava Consulting Group
Date: 2 weeks ago
City: Panchkula, Haryana
Salary:
₹18,000
-
₹24,000
per month
Contract type: Full time
Skills:
iso13485, Medical Devices, SOPs, Quality Assurance, Validation, Quality Control,
Purpose of the Role: To ensure quality management systems are implemented and maintained always Responsibilities:
To handle all activities related to quality management system, 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 1-2 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
iso13485, Medical Devices, SOPs, Quality Assurance, Validation, Quality Control,
Purpose of the Role: To ensure quality management systems are implemented and maintained always Responsibilities:
To handle all activities related to quality management system, 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 1-2 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
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