Quality Assurance Regulatory Affairs Manager Frido

5.0 - 7.0 years

0 Lacs

pune, maharashtra, india

On-site

Key Responsibilities: Location: Pune Regulatory Compliance: Ensure adherence to ISO 13485, EN ISO 13485, USFDA, SFDA, UKCA, and CE certification standards. Quality Management Systems (QMS): Implement and maintain robust QMS to comply with regulatory standards. Technical Documentation: Prepare and review technical files for regulatory submissions, ensuring accuracy and completeness. Risk Management: Apply ISO 14971 guidelines for risk assessment and mitigation in the product lifecycle. Audits & Inspections: Conduct internal audits, manage external regulatory audits, and ensure readiness for inspections by authorities such as FDA, MHRA, and SFDA. Change Management: Manage post-market surveilla...

Posted 3 weeks ago

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System Engineer Cyient

5.0 - 7.0 years

0 Lacs

pune, maharashtra, india

On-site

JD for System Engineer provided by Philips team Primary Skills: typically 5+ Years of experience Bachelor's degree in Electronics or Electronics and Telecommunication. Experience: As a system engineer or in a similar role, with a strong understanding of system architecture and integration. Understanding and awareness of ISO 13485 and ISO 14971 standards, as well as CE certification and knowledge of FDA audits will be beneficial. Technical Skills: Proficiency in system design and development principles. Experience with various medical systems and system software, along with knowledge of LCM and NPI processes. Experience with X-ray systems will be beneficial. Problem-Solving: Strong analytical...

Posted 2 months ago

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Electrical Maintenance Engineer Fermex Solutions LLP

1.0 - 5.0 years

0 Lacs

punjab

On-site

You should have basic knowledge about electrical components like relay, DC & AC drives. Your responsibilities will include studying wiring standards, assisting in UL and CE certifications, implementing wiring standards, checking BOM as per applicable standards, verifying wiring diagrams, material testing reports, panel testing reports, vessel testing reports, and maintaining a Quality File. You will also assist in creating a Quality Training Program. Additionally, you will be responsible for configuring CCTV cameras, printers, and should have knowledge about software and laptop maintenance. This is a full-time, permanent position that requires a Bachelor's degree and at least 1 year of exper...

Posted 4 months ago

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Mechanical CAD Designer Ikamate HR India Pvt.Ltd

1.0 - 5.0 years

0 Lacs

ahmedabad, gujarat

On-site

You will be joining a renowned Pharma Equipments Mfg Co. as a Technical Assistant Design. In this role, you will be responsible for creating technical drawings using software such as AUTOCAD & 3D (Solid Works). You should have the ability to interpret vessel drawings with detailed Bill of Quantities (BOQ) in accordance with CE certification and U-stamp requirements. Additionally, you will be required to work on Heat Exchanger drawings with detailed BOQ, possess knowledge of Machining Tolerances, and understand assembly parts. To excel in this position, you must be familiar with P & I Diagrams, General Arrangement (G.A.) Drawings, and Process Flow Charts. Knowledge of ISO 9001-2015 policies a...

Posted 4 months ago

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