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• Consulting/Contract

• UG :- - Not Required

• PG :- - Not Required

• No of position :- ( 1 )

• Post :- 15th Jun 2021

Mandatory Skills:- Medical - ISO13485 Process Expert

IEC 14971-Risk Mgmt for Medical Devices Expert

Project Management Expert

Desired Skills:- 21CFR Part 820-Quality System regulation& EUMDR Good

Agile Product Quality Management Knowledge

Good Communication and documentation skills.

Job Description:- • Experience & knowledge of Quality Management Systems based on ISO 13485:2016.

• Experience & knowledge of Risk Management Systems based on ISO 14971.

• Experience in EU Medical Device Regulation (2017/745) & FDA 21 CFR part 820.

• Knowledge on Engineering change management tools.

• Responsible for on-time projects delivery and to ensure the Quality of deliverables.

• Proactively work towards being a better problem solver while developing methods and parameters, project methodology and/ or project proposals.

• Cross functional team interaction and should have good experience of working in an onsite / offshore model