30 Job openings found

Experience to prepare and review the documentation required for the ISO 9001:2015, EN ISO 13485: 2016, Quality management System, WHO-GMP, EU MDR 2017/745, IMDR 2017. Knowledge and preparing documents such as Quality Manual, Site Master File, SOP’s, Change Control, Deviation, CAPA, Incident, and Customer complaint, Management Review Meeting, pdate Harmonized Standards, ...

Purpose of Role: Additional Technical Safety Engineer of major projects for all the phases of execution starting from Bid Engineering, Post Contract basic Engineering, Detailed Engineering, Follow on Engineering & Safety related Regulatory Compliance / FSA Close out / Final Project Documentation. In addition, function as Deputy Lead /Senior Specialist ...

Field Executive Job Description As a Field Executive, you will be responsible for carrying out various tasks assigned by the management that require you to be physically present at different locations. Your primary responsibilities will include conducting site visits, collecting and documenting data, providing support to customers or clients, and performing ...

Purchase Executive Job Description As a Purchase Executive, you will play a vital role in supporting the company's operations by managing the procurement process. You will work closely with suppliers and internal stakeholders to ensure the timely and cost-effective acquisition of goods and services. This role requires strong negotiation skills, attention ...

Import Export Executive Job Description As an Import Export Executive, you will be responsible for overseeing the import and export operations of the company. This includes managing shipments, coordinating with customs authorities, and ensuring all documentation is complete and accurate. You will work closely with suppliers, freight forwarders, and other stakeholders ...

Quality Assurance Specialist Responsibilities: Ensure product quality and conformity to regulatory standards, including Medical Device Regulation (MDR) and Quality Management System (QMS). Conduct internal quality audits and participate in management review meetings. Handle investigations of complaints and implement corrective and preventive actions. Maintain and update quality manuals, formats, and standard operating procedures (SOPs) in ...

Knowledge of  Clinical Evaluation Reports (CER) as per EU MDR, MEDDEV 2.7/1 Rev 4. Perform the risk benefit analysis as per ISO 14971 to demonstrate the medical device benefits outweighed the residual risk. Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, PMS and PMCF Plans/Reports, SSCPs, Regulatory Responses ...

Job Responsibilities: Monitoring of inbox, assignment of tasks to others ensuring that all queries have been responded to on time Artwork review and approval Creation and maintenance of master labelling specifications Release of product for further processing at EMP Creation of international registration documents Maintenance of technical drive, ensuring document compliance MDR/Technical file support Post Market Surveillance – ...

Key Responsibilities:  Client Relationship Management: Build and maintain strong relationships with enterprise clients, understanding their business objectives and aligning our services to meet their needs. Act as the main point of contact for clients, addressing concerns, resolving issues, and proactively communicating updates. Service Delivery Oversight: Oversee the end-to-end delivery of Enterprise Managed Services, ...

Job Location: Gurgaon  Job Title: Post Market Surveillance Associate  Essential Duties and Responsibilities. The incumbent will perform other duties as assigned.  • Implementation of the Post Market Surveillance requirements as part of the EU Medical Device Regulations including: o Gap assessment of current processes and regulatory requirements; o Implementation of ...