Job Description

Purpose of the Role: To ensure quality management systems are implemented and maintained always Responsibilities: \xef\x82\xb7 To handle all activities related quality management system, Quality Assurance & regulatory affairs for ISO 9001 & 13485, 93/42/EEC Directive including- \xef\x82\xb7 Technical files making & updating including risk management, clinical evaluation, post market surveillance, quality plan, ESRs, etc. \xef\x82\xb7 Fulfilment of regulatory requirements related to EC directive, various Govt. tenders & registration of overseas. \xef\x82\xb7 Follow up of local regulatory & drugs requirements. \xef\x82\xb7 Validation- machines, processes, clean rooms, material & sterilization. \xef\x82\xb7 Organizing internal & external audits including notified bodies audits related to quality management system & CE and follow up of non-closure reports. \xef\x82\xb7 Dealing in customer complaints, investigating, root cause analysis and replying, vigilance reporting & recall. \xef\x82\xb7 MRM- Organizing & follow up actions from previous meetings. \xef\x82\xb7 Review & modification in all the SOPs & manuals. \xef\x82\xb7 Master list of records- Establishment & updating. \xef\x82\xb7 Master list of documents- Establishment & updating. \xef\x82\xb7 Deviations- Follow up & records \xef\x82\xb7 Corrective & preventive actions- Corrections, implementations & maintenance. \xef\x82\xb7 Calibration of equipment and machines of production & quality control. \xef\x82\xb7 Handling out the pre-dispatch inspections of shipments by the outside agencies and certification bodies. \xef\x82\xb7 Training- Planning & Imparting Requirements: \xef\x82\xb7 Work experience should be minimum 1-2 years in medical devices manufacturing. \xef\x82\xb7 Excellent computer skills \xef\x82\xb7 Goal Oriented \xef\x82\xb7 Strong communication skills, including the ability to explain and teach methodologies \xef\x82\xb7 Understanding of manufacturing methods and quality standards \xef\x82\xb7 A confident and determined approach \xef\x82\xb7 Excellent organizational & time management skills \xef\x82\xb7 Team player Job Type: Full-time Salary: 920,000.00 - 930,000.00 per month Schedule:

• Day shift

Supplemental pay types:

• Yearly bonus

Ability to commute/relocate:

• Okhla, Delhi, Delhi: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor\'s (Preferred)

Experience:

• total work: 1 year (Required)

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