US: Senior QA Engineer
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Senior QA Engineer
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.
BS in Mechanical- any discipline
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Team SQAFYI - Software QA Resource FYI