5.0 - 10.0 years

0 - 1 Lacs

Bengaluru

Work from Office

Job Title: QARA ENGINEER Experience: 4.5 to 10 years Location: Bangalore Mandatory Skill: US FDA, 510K, PMA, EU MDR, QARA. Regulatory gap assessment and remediation. Job Description: The objective of this project is to identify and remediate any deficiencies in the design history files (DHF) and device master records (DMR) of the stent graft integrated with 4 branched vascular prosthesis - FROZENIX 4 Branched, ensuring adherence to relevant standards, US Food and Drug Administration ("FDA") guidelines and regulations requirements by completing all necessary tasks including document translation (Japanese to English), gap assessment, remediation and submission query support. Design verification and Validation US FDA 510k submission process US FDA Premarket approval ISO 14971 - Medical device risk management DHF Gap assessment DMR Gap assessment EU MDR 2017/745 regulations CE Technical documentation Technical standards and guidance (for medical device) ISO 60601 Electrical safety IEC 62304 - Human factors and Usability engineering ISO 10993 - Biocompatibility testing

Posted 2 weeks ago

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D365 F&O Finance Functional Consultant Claranet Group

5.0 - 8.0 years

14 - 24 Lacs

Hyderabad

Remote

We at Claranet are looking for F&O Finance Functional Professionals who will be involved in all aspects of implementing supporting Dynamics solutions through the project life cycle to go live and ongoing support. You can contribute to Solution Design sessions, help with configuration, help with data migration deliverables, create required interface design and functional design documents, troubleshoot customization, etc. Role- D365 F&O Functional Consultant (Full Time) Office Location Hitech, Hyderabad - India Working mode : Remote Interested Candidates can your CV on Rakesh.koyya@claranet.com Key Responsibilities: Analyze business processes (Finance, PMA) to identify opportunities for improvement. Identify creative workarounds to meet requirements without the development of custom code. Understand the functional capabilities and limitations for out-of-the-box functionality as well as custom code. You will be the one to identify our customers' requirements and match them with technological capabilities and with Microsoft continuous release plans. Key Competencies: Deep functional knowledge of Microsoft Dynamics 365 Finance and PMA. Experience of customized solutions to complex business problems. Demonstrable consultancy experience. Strong working knowledge of business processes and ER framework. Relevant Microsoft certification. Excellent documentation and communication skills. A logical approach to problem-solving and the structured introduction of change into operational systems. Ability to multitask and prioritize. Good interpersonal skills. Attention to detail. Skills Required: Hold 6-8 years of experience within D365 F&O implementation, support Specialized in Finances, PMA, Integration, ER reports Qualified Chartered Accountant / MBA (Finance) desirable Are fluent in English. Strong communication and consulting skills Global Exposure must (Interacting with Global clients/customers) Company Benefits: Group Medical Insurance (including parents coverage), Group Term Life Policy and Personal Accidental Policy Tax Saving flexible benefits Flexible working hours Statutory Benefits (PF, Gratuity)

Posted 1 month ago

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Urgent hiring For Instrumentation Section Head - Baddi Samridhi

7.0 - 12.0 years

6 - 12 Lacs

Baddi

Work from Office

Role & responsibilities 1. To control and maintain distributed control system and ensure its availability to the plant. 2. To carry out computerized maintenance system connected jobs and ensure adherence to all compliances as per IMS guidelines. 3. Responsible for carrying out the breakdown review for the FIR/FAR system to adopt corrective and preventive actions after breakdowns and to determine the root cause of breakdowns. 4. To look after the manpower management of the department with emphasis on continuous development of the team members through trainings/knowledge sharing sessions. 5. To ensure regular correspondence with suppliers or partners for the development of the new system, control, or device by utilizing new or alternate technology. 6. To look after the preparation and revision of SOPs of the department. 7. To plan and coordinate with production departments for required modification in the plant through PMA’s(Preventive Maintenance activities) 8. To maintain an optimum spares inventory for the department as per the vitality of equipment with regular reviews. 9. To make sure interlock checks are performed in accordance with the established timetable and to maintain an accurate interlock list for the department. 10. To ensure completion and implementation of the assigned projects with in defined time and budget.

Posted 1 month ago

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