SQAFYI - Software QA Resource - FYI

US: Senior QA Engineer

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 02-Apr-2018

Senior QA Engineer

Job Description: Generate Design History file (DHF) & Risk Management file (RMF) technical documents for surgical legacy products in support of the 2018 MDR Technical File conversion activities. Review, analyze and synthesize product technical documents of products. Write new documents and release to DHF/RMF Update Risk Management Reports and DHF indice Lead resolution of technical documentation issues with each MDR product team Develop or revise product requirements and traceability matrices. Plan, coordinate, and deliver complete DHF and RMF on time per MDR Tech file conversion schedule following FDA Quality System Regulation, ISO requirements, and European Medical Device Directives Support the development and implementation of quality engineering for design controls, risk management, change control, post market review, quality planning, and establishment of appropriate requirements management and traceability. Responsible for engineering documentation Support the implementation of assurances, process controls, and CAPAs / systems designed to meet or exceed internal and external requirements. Work with R & D staff to ensure regulatory compliance to GMP’s of all medical device regulatory agencies (e.g., FDA, ISO and MDD). Interface with Physicians and hospital personnel to obtain feedback on concepts and performance of new devices. Translate customer needs into product requirements and design specifications.

Job requirements:

BS in Mechanical- any discipline

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Thank you,
Team SQAFYI - Software QA Resource FYI

US: Senior QA Engineer